Trial Outcomes & Findings for Description of the Population With Genitourinary Tumors and COVID-19 (NCT NCT04578132)
NCT ID: NCT04578132
Last Updated: 2025-04-01
Results Overview
Describe the population infected by COVID-19 with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) treated in Spanish hospitals, know the clinical presentation: Spcifically here we reported the Age
Recruitment status
COMPLETED
Target enrollment
410 participants
Primary outcome timeframe
Baseline, at the time of inclusion
Results posted on
2025-04-01
Participant Flow
Participant milestones
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Overall Study
STARTED
|
410
|
|
Overall Study
COMPLETED
|
410
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Description of the Population With Genitourinary Tumors and COVID-19
Baseline characteristics by cohort
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=408 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
357 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
408 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Smoking status
Never
|
136 Participants
n=5 Participants
|
|
Smoking status
Ever
|
231 Participants
n=5 Participants
|
|
Smoking status
UK
|
41 Participants
n=5 Participants
|
|
Comorbities
Hypertension
|
224 Participants
n=5 Participants
|
|
Comorbities
Diabetes
|
92 Participants
n=5 Participants
|
|
Comorbities
Cardiopathy
|
79 Participants
n=5 Participants
|
|
Comorbities
COPD / Asma
|
57 Participants
n=5 Participants
|
|
Comorbities
Hepatopathy
|
19 Participants
n=5 Participants
|
|
Comorbities
Nephropathy
|
53 Participants
n=5 Participants
|
|
Comorbities
None
|
121 Participants
n=5 Participants
|
|
Cancer type
Prostate
|
166 Participants
n=5 Participants
|
|
Cancer type
Urothelial
|
128 Participants
n=5 Participants
|
|
Cancer type
Kidney
|
90 Participants
n=5 Participants
|
|
Cancer type
Testicular
|
23 Participants
n=5 Participants
|
|
Cancer type
Penile
|
1 Participants
n=5 Participants
|
|
Clinical cancer stage at cancer diagnosis;
0
|
2 Participants
n=5 Participants
|
|
Clinical cancer stage at cancer diagnosis;
I
|
54 Participants
n=5 Participants
|
|
Clinical cancer stage at cancer diagnosis;
II
|
64 Participants
n=5 Participants
|
|
Clinical cancer stage at cancer diagnosis;
III
|
90 Participants
n=5 Participants
|
|
Clinical cancer stage at cancer diagnosis;
IV
|
166 Participants
n=5 Participants
|
|
Clinical cancer stage at cancer diagnosis;
UK
|
32 Participants
n=5 Participants
|
|
Time from cancer diagnosis to SARS-CoV-2 infection
|
32 months
n=5 Participants
|
|
Clinical cancer stage at SARS-CoV-2 infection
o
|
24 Participants
n=5 Participants
|
|
Clinical cancer stage at SARS-CoV-2 infection
I
|
19 Participants
n=5 Participants
|
|
Clinical cancer stage at SARS-CoV-2 infection
II
|
22 Participants
n=5 Participants
|
|
Clinical cancer stage at SARS-CoV-2 infection
III
|
29 Participants
n=5 Participants
|
|
Clinical cancer stage at SARS-CoV-2 infection
IV
|
291 Participants
n=5 Participants
|
|
Clinical cancer stage at SARS-CoV-2 infection
UK
|
23 Participants
n=5 Participants
|
|
Histopathological grade at SARS-CoV-2 infection
Well differentiated
|
31 Participants
n=5 Participants
|
|
Histopathological grade at SARS-CoV-2 infection
Moderately differentiated
|
61 Participants
n=5 Participants
|
|
Histopathological grade at SARS-CoV-2 infection
Poorly differentiated
|
136 Participants
n=5 Participants
|
|
Histopathological grade at SARS-CoV-2 infection
UK
|
180 Participants
n=5 Participants
|
|
Anticancer treatment status at SARS-CoV-2 infection
Active
|
238 Participants
n=5 Participants
|
|
Anticancer treatment status at SARS-CoV-2 infection
Follow-up
|
170 Participants
n=5 Participants
|
|
Anticancer treatment type at SARS-CoV-2 infection
Neo-adjuvant
|
8 Participants
n=5 Participants
|
|
Anticancer treatment type at SARS-CoV-2 infection
Adjuvant
|
10 Participants
n=5 Participants
|
|
Anticancer treatment type at SARS-CoV-2 infection
Metastatic / palliative
|
219 Participants
n=5 Participants
|
|
Anticancer treatment type at SARS-CoV-2 infection
UK
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, at the time of inclusionPopulation: Describe the population infected by COVID-19 with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) treated in Spanish hospitals
Describe the population infected by COVID-19 with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) treated in Spanish hospitals, know the clinical presentation: Spcifically here we reported the Age
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=408 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Age at Baseline
|
70 years
Interval 17.0 to 100.0
|
PRIMARY outcome
Timeframe: Through study completion, average 1 yearPopulation: Describe the population infected by COVID-19 with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) treated in Spanish hospitals
Percentage of patients with complications associated to COVID-19 infection (classified by type and severity)
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=408 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Frequency of Complications of COVID-19 Intercurrent Infection
Death secondary to infectioninfection
|
73 Participants
|
|
Frequency of Complications of COVID-19 Intercurrent Infection
ICU admission due to need of symptom control
|
5 Participants
|
|
Frequency of Complications of COVID-19 Intercurrent Infection
Hospital admission due to need of symptom control
|
136 Participants
|
|
Frequency of Complications of COVID-19 Intercurrent Infection
Need for mechanical ventilation
|
3 Participants
|
|
Frequency of Complications of COVID-19 Intercurrent Infection
No complications. Common infection at home
|
191 Participants
|
PRIMARY outcome
Timeframe: Through study completion, average 1 yearTo assess the possible relationship of the different oncological treatments administered to these patients with the clinical evolution of the COVID-19 infection. Complications will be classified by type and severity in groups of patients stratified by the oncological treatment received.
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=408 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by Treatment
Immunotherapy treatment/no Pneumonia
|
51 Participants
|
|
Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by Treatment
Immunotherapy treatment/ Pneumonia
|
36 Participants
|
|
Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by Treatment
No Immunotherapy treatment/no Pneumonia
|
181 Participants
|
|
Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by Treatment
No Immunotherapy treatment/Pneumonia
|
140 Participants
|
PRIMARY outcome
Timeframe: Through study completion, average 1 yearTo evaluate in patients with Genitourinary Cancer the impact of androgen deprivation therapy (ADT) and new antiandrogenic agents (NAH) with or without corticosteroids on the infection COVID-19 as mean of frequency in complications of COVID-19 infection classified by type and severity
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=408 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment
Corticosteroid treatment/ no Pneumonia
|
59 Participants
|
|
Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment
Corticosteroid treatment/ si Pneumonia
|
55 Participants
|
|
Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment
No Corticosteroid treatment/ no Pneumonia
|
173 Participants
|
|
Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment
No Corticosteroid treatment/ si Pneumonia
|
120 Participants
|
|
Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment
UK
|
1 Participants
|
PRIMARY outcome
Timeframe: Through study completion, average 1 yearTo assess the possible relationship of the different oncological treatments administered to these patients with the clinical evolution of the COVID-19 infection. Complications will be classified by type and severity in groups of patients stratified by the oncological treatment received.
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=408 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy)
Immunotherapy treatment /no complications
|
45 Participants
|
|
Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy)
Immunotherapy treatment /admissions
|
31 Participants
|
|
Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy)
Immunotherapy treatment /Death secondary to infection
|
11 Participants
|
|
Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy)
No Immunotherapy treatment /no complications
|
146 Participants
|
|
Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy)
No Immunotherapy treatment /admissions
|
113 Participants
|
|
Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy)
No Immunotherapy treatment /Death secondary to infection
|
62 Participants
|
PRIMARY outcome
Timeframe: Through study completion, average 1 year. Measured at 3 scenarios (during treatment, after treatment and therapies indicated after infection has passed)To specifically assess the impact of COVID-19 infection on the toxicity of immunotherapy treatment (mainly pneumonitis) and the impact of immunotherapy on the evolution of the infectious picture in patients with tumors of genitourinary origin. three different scenarios: during treatment, after treatment and in patients who receive treatment after the infection has passed.
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=87 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
Arthritis G1
|
1 Participants
|
|
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
Colitis G1
|
1 Participants
|
|
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
Colitis G3
|
1 Participants
|
|
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
Hepatitis G2
|
3 Participants
|
|
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
Hepatitis G3
|
3 Participants
|
|
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
Hepatitis G4
|
1 Participants
|
|
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
Hypophysitis G2
|
1 Participants
|
|
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
Nephritis G1
|
1 Participants
|
|
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
Nephritis G2
|
1 Participants
|
|
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
Nephritis G3
|
1 Participants
|
|
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
Nephritis G4
|
1 Participants
|
|
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
Pneumonitis G2
|
1 Participants
|
|
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
Thyroiditis G1
|
2 Participants
|
|
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
Thyroiditis G2
|
2 Participants
|
|
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
Arthritis G3
|
1 Participants
|
|
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
Colitis G2
|
1 Participants
|
SECONDARY outcome
Timeframe: Through study completion, average 1 yearTo assess the mortality associated with COVID-19 infection in the population with genitourinary tumors. Percentage of patients alive / dead at discharge.
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=408 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
COVID-19 Mortality Rate in Patients With Genitourinary Cancer
Alive
|
137 Participants
|
|
COVID-19 Mortality Rate in Patients With Genitourinary Cancer
Dead
|
80 Participants
|
|
COVID-19 Mortality Rate in Patients With Genitourinary Cancer
NA
|
191 Participants
|
SECONDARY outcome
Timeframe: Through study completion, average 1 yearEvaluate the rate (percentage) of complications that have required hospital admission and / or ICU treatment. Complications will be classified by type and severity and represented as percentage of patients presenting them.
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=408 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
COVID-19 Complication Rate in Patients With Genitourinary Cancer
Death secondary to infection
|
73 Participants
|
|
COVID-19 Complication Rate in Patients With Genitourinary Cancer
ICU admission due to need of symptom control
|
5 Participants
|
|
COVID-19 Complication Rate in Patients With Genitourinary Cancer
Hospital admission due to need of symptom control
|
136 Participants
|
|
COVID-19 Complication Rate in Patients With Genitourinary Cancer
Need for mechanical ventilation
|
3 Participants
|
|
COVID-19 Complication Rate in Patients With Genitourinary Cancer
No complications. Common infection at home
|
191 Participants
|
SECONDARY outcome
Timeframe: Through study completion, average 1 yearDescribe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=408 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Asymptomatic Rate
symptomatic
|
308 Participants
|
|
Asymptomatic Rate
Asymptomatic
|
100 Participants
|
SECONDARY outcome
Timeframe: Through study completion, average 1 yearDescribe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=90 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Asymptomatic Rate in Renal Cancer
Symptomatic
|
63 Participants
|
|
Asymptomatic Rate in Renal Cancer
Asymptomatic
|
27 Participants
|
SECONDARY outcome
Timeframe: Through study completion, average 1 yearDescribe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=128 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Asymptomatic Rate in Urothelial Cancer
Asymptomatic
|
32 Participants
|
|
Asymptomatic Rate in Urothelial Cancer
Symptomatic
|
96 Participants
|
SECONDARY outcome
Timeframe: Through study completion, average 1 yearDescribe the frequency of asymptomatic or minimally symptomatic COVID-19 infections
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=166 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Asymptomatic Rate in Prostate Cancer
Asymptomatic
|
33 Participants
|
|
Asymptomatic Rate in Prostate Cancer
Symptomatic
|
133 Participants
|
SECONDARY outcome
Timeframe: Through study completion, average 1 yearDescribe the frequency of asymptomatic or minimally symptomatic COVID-19 infections
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=21 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Asymptomatic Rate in Testicular Cancer
asymptomatic
|
6 Participants
|
|
Asymptomatic Rate in Testicular Cancer
symptomatic
|
15 Participants
|
SECONDARY outcome
Timeframe: Through study completion, average 1 yearPopulation: Patients with genitourinary tumor presenting Covid-19 infection with prospective part who start/restart treatment
delays / modifications in cancer follow-up or treatment regimens.
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=326 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Frequency of Delays/Modifications on Cancer Treatment Schedule
Start Treatment after COVID-19
|
20 Participants
|
|
Frequency of Delays/Modifications on Cancer Treatment Schedule
Restart Treatment after COVID-19
|
146 Participants
|
|
Frequency of Delays/Modifications on Cancer Treatment Schedule
With treatment after COVID-19 without specifying start/restart
|
6 Participants
|
|
Frequency of Delays/Modifications on Cancer Treatment Schedule
Without oncology treatment after COVID-19 (reported)
|
154 Participants
|
SECONDARY outcome
Timeframe: Through study completion, average 1 yearPopulation: Patients with genitourinary tumor presenting Covid-19 infection with prospective part witn treatment modifications
delays / modifications in cancer follow-up or treatment regimens.
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=38 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Frequency of Delays/Modifications on Cancer Treatment Schedule
Change in administration schedule
|
15 Participants
|
|
Frequency of Delays/Modifications on Cancer Treatment Schedule
Temporary suspension of treatment
|
22 Participants
|
|
Frequency of Delays/Modifications on Cancer Treatment Schedule
Dose
|
1 Participants
|
SECONDARY outcome
Timeframe: Through study completion, average 1 yearPopulation: Patients with genitourinary tumor presenting Covid-19 infection with prospective part
delays / modifications in cancer follow-up or treatment regimens.
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=326 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Frequency of Delays/Modifications on Cancer Treatment Schedule
Yes Treatment modification (prospective visit)
|
38 Participants
|
|
Frequency of Delays/Modifications on Cancer Treatment Schedule
No Treatment modification (prospective visit)
|
108 Participants
|
|
Frequency of Delays/Modifications on Cancer Treatment Schedule
New treatment o no treatment start date
|
24 Participants
|
|
Frequency of Delays/Modifications on Cancer Treatment Schedule
NA/UK
|
156 Participants
|
SECONDARY outcome
Timeframe: From start of treatment until progression or death, up to 130 monthsPopulation: Patients with genitourinary tumors that suffered COVID-19. Only patients with a first line treatment ongoing at the moment of COVID infection were analyzed.
It is expected to obtain data on time to progression and overall survival of cancer patients, which can be compared with the reference values for each type of tumor pathology. PROGRESSION FREE SURVIVAL (FIRST LINE IN METASTATIC OR ADVANCED SETTING) The date of treatment start (treatment ongoing at the moment of COVID infection) is taken as the start date of follow-up. Only patients with a first line treatment ongoing at the moment of COVID infection were analyzed.
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=56 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Progression Free Survival in Patients With Genitourinary Tumors That Suffered COVID-19, Patients With a First Line Treatment Ongoing at the Moment of COVID Infection
Renal
|
93.26 months
Interval 45.62 to 140.91
|
|
Progression Free Survival in Patients With Genitourinary Tumors That Suffered COVID-19, Patients With a First Line Treatment Ongoing at the Moment of COVID Infection
Urothelial
|
80.13 months
Interval 28.38 to 131.88
|
|
Progression Free Survival in Patients With Genitourinary Tumors That Suffered COVID-19, Patients With a First Line Treatment Ongoing at the Moment of COVID Infection
Prostate
|
121.94 months
Interval 96.68 to 147.2
|
SECONDARY outcome
Timeframe: From start of treatment until progression or death, up to 130 monthsPopulation: Patients with genitourinary tumor presenting Covid-19 infection with prospective part
It is expected to obtain data on time to progression and overall survival of cancer patients, which can be compared with the reference values for each type of tumor pathology. For the calculation of overall survival, it is taken from the date of cancer diagnosis to the date of death (at any time, not only in a prospective part).
Outcome measures
| Measure |
Genitourinary Cancer Patients That Suffered COVID-19
n=405 Participants
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
|
|---|---|
|
Overall Survival in Patients With Genitourinary Tumors That Suffered COVID-19
Renal
|
18.36 years
Interval 14.51 to 22.22
|
|
Overall Survival in Patients With Genitourinary Tumors That Suffered COVID-19
Urothelial
|
7.03 years
Interval 4.91 to 9.14
|
|
Overall Survival in Patients With Genitourinary Tumors That Suffered COVID-19
Prostate
|
11.49 years
Interval 9.85 to 13.13
|
|
Overall Survival in Patients With Genitourinary Tumors That Suffered COVID-19
Testicular
|
24.37 years
Interval 19.97 to 28.76
|
Adverse Events
Adverse Events
Serious events: 0 serious events
Other events: 22 other events
Deaths: 152 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adverse Events
n=87 participants at risk
Adverse events reported by those patients on active immunotherapy by the time of SARS-CoV-2 infection.
The main scope of this trial was not safety. Therefore, the study did not record adverse events in patients treated with other therapies. The study did not record serious adverse events sistematically.
This partial information about safety was the only information of adverse events collected during this observational study.
|
|---|---|
|
Hepatobiliary disorders
Hepatitis
|
8.0%
7/87 • 2 year Note: Adverse events were only collected and reported by those patients on active immunotherapy by the time of SARS-CoV-2 infection (n=87)
Adverse events were only collected and reported in the subgroup of patients treated with immunotherapy (n=87) All cause mortality reported in the overall population
|
|
General disorders
Nephritis
|
4.6%
4/87 • 2 year Note: Adverse events were only collected and reported by those patients on active immunotherapy by the time of SARS-CoV-2 infection (n=87)
Adverse events were only collected and reported in the subgroup of patients treated with immunotherapy (n=87) All cause mortality reported in the overall population
|
|
Endocrine disorders
Thyroiditis
|
4.6%
4/87 • 2 year Note: Adverse events were only collected and reported by those patients on active immunotherapy by the time of SARS-CoV-2 infection (n=87)
Adverse events were only collected and reported in the subgroup of patients treated with immunotherapy (n=87) All cause mortality reported in the overall population
|
|
Infections and infestations
Colitis
|
3.4%
3/87 • 2 year Note: Adverse events were only collected and reported by those patients on active immunotherapy by the time of SARS-CoV-2 infection (n=87)
Adverse events were only collected and reported in the subgroup of patients treated with immunotherapy (n=87) All cause mortality reported in the overall population
|
|
General disorders
Arthritis
|
2.3%
2/87 • 2 year Note: Adverse events were only collected and reported by those patients on active immunotherapy by the time of SARS-CoV-2 infection (n=87)
Adverse events were only collected and reported in the subgroup of patients treated with immunotherapy (n=87) All cause mortality reported in the overall population
|
|
Infections and infestations
Pneumonitis
|
1.1%
1/87 • 2 year Note: Adverse events were only collected and reported by those patients on active immunotherapy by the time of SARS-CoV-2 infection (n=87)
Adverse events were only collected and reported in the subgroup of patients treated with immunotherapy (n=87) All cause mortality reported in the overall population
|
|
Endocrine disorders
Hypophysitis
|
1.1%
1/87 • 2 year Note: Adverse events were only collected and reported by those patients on active immunotherapy by the time of SARS-CoV-2 infection (n=87)
Adverse events were only collected and reported in the subgroup of patients treated with immunotherapy (n=87) All cause mortality reported in the overall population
|
Additional Information
A person designated by the Sponsor
An organization designated by the Sponsor
Phone: +34934344412
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place