Trial Outcomes & Findings for Incidence and Prevalence of Cancer in People Living With HIV/AIDS at Cancer Centers in Latin America (NCT NCT04089488)

NCT ID: NCT04089488

Last Updated: 2023-09-01

Results Overview

The primary endpoint will be the estimates of site-specific frequency of new diagnosis and existing cases (recurrence and surveillance) presenting with HIV and cancer presenting over 1 year, 9 months (21 months) at the clinical sites.

Recruitment status

COMPLETED

Target enrollment

175 participants

Primary outcome timeframe

Up to 21 months

Results posted on

2023-09-01

Participant Flow

Participant milestones

Participant milestones
Measure
Observational (Respond to Surveys, Medical Record Review)
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks. Medical Chart Review: Correlative studies Survey Administration: Respond to surveys
Overall Study
STARTED
175
Overall Study
COMPLETED
175
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Incidence and Prevalence of Cancer in People Living With HIV/AIDS at Cancer Centers in Latin America

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Observational (Respond to Surveys, Medical Record Review)
n=175 Participants
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks. Medical Chart Review: Correlative studies Survey Administration: Respond to surveys
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
167 Participants
n=5 Participants
Age, Categorical
>=65 years
8 Participants
n=5 Participants
Age, Continuous
39 years
n=5 Participants
Sex: Female, Male
Female
37 Participants
n=5 Participants
Sex: Female, Male
Male
138 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
171 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
13 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
15 Participants
n=5 Participants
Race (NIH/OMB)
White
47 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
100 Participants
n=5 Participants
Region of Enrollment
Argentina
26 participants
n=5 Participants
Region of Enrollment
Brazil
49 participants
n=5 Participants
Region of Enrollment
Mexico
100 participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to 21 months

Population: There are five study sites (Complexo Hospitalar; Hospital Fernandez; Hospital Roff0; Instituto Nacional De Cancer Brazil ; and Instituto de Oncologia). Given a study site, new diagnosis and existing cases(recurrence and surveillance) are summarized.

The primary endpoint will be the estimates of site-specific frequency of new diagnosis and existing cases (recurrence and surveillance) presenting with HIV and cancer presenting over 1 year, 9 months (21 months) at the clinical sites.

Outcome measures

Outcome measures
Measure
Observational (Respond to Surveys, Medical Record Review)
n=175 Participants
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks. Medical Chart Review: Correlative studies Survey Administration: Respond to surveys
Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites
Hospital Fernandez (surveillance)
5 Participants
Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites
Hospital Roffo (new diagnosis)
3 Participants
Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites
Instituto de Oncologia (new diagnosis)
27 Participants
Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites
Complexo Hospitalar Professor Edgard Santos (new diagnosis)
13 Participants
Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites
Complexo Hospitalar Professor Edgard Santos (recurrence)
4 Participants
Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites
Complexo Hospitalar Professor Edgard Santos (surveillance)
10 Participants
Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites
Hospital Fernandez (new diagnosis)
10 Participants
Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites
Hospital Fernandez (recurrence)
2 Participants
Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites
Hospital Roffo (recurrence)
2 Participants
Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites
Hospital Roffo (surveillance)
4 Participants
Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites
Instituto Nacional De Cancer Brazil (new diagnosis)
11 Participants
Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites
Instituto Nacional De Cancer Brazil (recurrence)
2 Participants
Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites
Instituto Nacional De Cancer Brazil (surveillance)
9 Participants
Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites
Instituto de Oncologia (recurrence)
9 Participants
Estimates of Site-specific Incident Cases and Site-specific Prevalence of Cases Presenting With Human Immunodeficiency Virus (HIV) and Cancer Presenting Over 9 Months at the Clinical Sites
Instituto de Oncologia (surveillance)
64 Participants

PRIMARY outcome

Timeframe: 21 months

Population: There are five study sites (Complexo Hospitalar; Hospital Fernandez; Hospital Roff0; Instituto Nacional De Cancer Brazil ; and Instituto de Oncologia). Given a study site, new diagnosis cases are summarized using cases per month.

The mean cases per month of incidence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months. This summary was based on the study site.

Outcome measures

Outcome measures
Measure
Observational (Respond to Surveys, Medical Record Review)
n=175 Participants
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks. Medical Chart Review: Correlative studies Survey Administration: Respond to surveys
Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.
Complexo Hospitalar Professor Edgard Santos (new diasgnosis)
0.62 New diagnosis cases per month
Interval 0.33 to 1.06
Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.
Instituto Nacional De Cancer Brazil (new diagnosis)
0.52 New diagnosis cases per month
Interval 0.26 to 0.94
Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.
Instituto de Oncologia (new diagnosis)
1.29 New diagnosis cases per month
Interval 0.84 to 1.87
Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.
Hospital Fernandez (new diagnosis)
0.48 New diagnosis cases per month
Interval 0.23 to 0.88
Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.
Hospital Roffo (new diagnosis)
0.14 New diagnosis cases per month
Interval 0.03 to 0.42

PRIMARY outcome

Timeframe: 21 months

Population: The numbers of participants per cancer type were displayed.

The mean cases per month of incidence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months. This summary was based on the cancer type.

Outcome measures

Outcome measures
Measure
Observational (Respond to Surveys, Medical Record Review)
n=175 Participants
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks. Medical Chart Review: Correlative studies Survey Administration: Respond to surveys
Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type.
Other (new diagnosis)
0.67 Mean cases per month
Interval 0.36 to 1.12
Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type.
Kaposi sarcoma (new diagnosis)
1.19 Mean cases per month
Interval 0.77 to 1.75
Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type.
Non-Hodgkin's Lymphoma (new diagnisis)
0.86 Mean cases per month
Interval 0.51 to 1.35
Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type.
Hodgkin's lymphoma (new diagnosis)
0.24 Mean cases per month
Interval 0.08 to 0.56
Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type.
Anal cancer (new diagnosis)
0 Mean cases per month
Interval 0.0 to 0.0
Mean Cases Per Month of New Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type.
Cervical cancer (new diagnosis)
0.10 Mean cases per month
Interval 0.01 to 0.34

PRIMARY outcome

Timeframe: 21 months

Population: The numbers of participants per study site were displayed.

The mean cases per month of prevalence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months. This summary was based on the study site.

Outcome measures

Outcome measures
Measure
Observational (Respond to Surveys, Medical Record Review)
n=175 Participants
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks. Medical Chart Review: Correlative studies Survey Administration: Respond to surveys
Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.
Complexo Hospitalar Professor Edgard Santos
.67 mean cases per month
Interval 0.36 to 1.12
Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.
Instituto Nacional De Cancer Brazil
0.52 mean cases per month
Interval 0.26 to 0.94
Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.
Instituto de Oncologia
3.48 mean cases per month
Interval 2.72 to 4.37
Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.
Hospital Fernandez
0.33 mean cases per month
Interval 0.13 to 0.69
Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Study Site.
Hospital Roffo
0.29 mean cases per month
Interval 0.1 to 0.62

PRIMARY outcome

Timeframe: 21 months

Population: The numbers of participants per cancer type were displayed.

The mean cases per month of prevalence will be estimated along with corresponding 95% Poisson confidence interval. The number of cases will be counted and mean cases per months will be estimated. Duration of observation was 21 months. This summary was based on the cancer type.

Outcome measures

Outcome measures
Measure
Observational (Respond to Surveys, Medical Record Review)
n=175 Participants
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks. Medical Chart Review: Correlative studies Survey Administration: Respond to surveys
Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type
Kaposi sarcoma
2.14 Mean cases per month
Interval 1.56 to 2.87
Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type
non-Hodgkin's Lymphoma
1.33 Mean cases per month
Interval 0.89 to 1.93
Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type
Hodgkin's Lymphoma
0.38 Mean cases per month
Interval 0.16 to 0.75
Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type
Anal cancer
0.14 Mean cases per month
Interval 0.03 to 0.42
Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type
Cervical cancer
0.14 Mean cases per month
Interval 0.03 to 0.42
Mean Cases Per Month of Existing Cases Were Estimated Along With Corresponding 95% Poisson Confidence Interval by Cancer Type
Other
1.14 Mean cases per month
Interval 0.73 to 1.7

SECONDARY outcome

Timeframe: Up to 21 months

The frequency of diagnostic testing modalities will be summarized for cancer.

Outcome measures

Outcome measures
Measure
Observational (Respond to Surveys, Medical Record Review)
n=175 Participants
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks. Medical Chart Review: Correlative studies Survey Administration: Respond to surveys
Information on the Use of Diagnostic Testing in HIV-positive Individuals
Histology (Other)
38 Participants
Information on the Use of Diagnostic Testing in HIV-positive Individuals
Unknown
1 Participants
Information on the Use of Diagnostic Testing in HIV-positive Individuals
Histology (Kaposi sarcoma)
62 Participants
Information on the Use of Diagnostic Testing in HIV-positive Individuals
Clinical only (Kaposi sarcoma)
7 Participants
Information on the Use of Diagnostic Testing in HIV-positive Individuals
Histology (Non-Hodgkin's lymphoma)
45 Participants
Information on the Use of Diagnostic Testing in HIV-positive Individuals
Cytology (Non-Hodgkin's lymphoma)
1 Participants
Information on the Use of Diagnostic Testing in HIV-positive Individuals
Histology (Hodgkin's lymphoma)
12 Participants
Information on the Use of Diagnostic Testing in HIV-positive Individuals
Cytology (Hodgkin's lymphoma)
1 Participants
Information on the Use of Diagnostic Testing in HIV-positive Individuals
Histology(Anal)
3 Participants
Information on the Use of Diagnostic Testing in HIV-positive Individuals
Histology (Cervical)
5 Participants

SECONDARY outcome

Timeframe: Up to 21 months

For each cancer, summary statistics will be used to describe the HIV treatment regimens and disease characteristics.

Outcome measures

Outcome measures
Measure
Observational (Respond to Surveys, Medical Record Review)
n=175 Participants
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks. Medical Chart Review: Correlative studies Survey Administration: Respond to surveys
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Kaposi sarcoma (NNRTI only)
17 Participants
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Kaposi sarcoma (Combination)
48 Participants
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Kaposi sarcoma (No HIV treatment)
5 Participants
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Non-Hodgkin's lymphoma (NNRTI only)
18 Participants
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Non-Hodgkin's lymphoma (Combination)
25 Participants
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Non-Hodgkin's lymphoma (No HIV treatment)
3 Participants
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Hodgkin's lymphoma (NNRTI only)
4 Participants
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Hodgkin's lymphoma (Combination)
8 Participants
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Hodgkin's lymphoma (No HIV treatment)
1 Participants
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Anal (NNRTI only)
1 Participants
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Anal (Combination)
2 Participants
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Cervical (Combination)
4 Participants
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Cervical (No HIV treatment)
1 Participants
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Other (NNRTI only)
21 Participants
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Other (Combination)
12 Participants
HIV Treatment and Disease Characteristics of HIV-positive Individuals Diagnosed With Cancer
Other (No HIV treatment)
5 Participants

SECONDARY outcome

Timeframe: Up to 21 months

The frequency of the Treatment for Cancers Diagnosed in HIV-positive Individuals will be summarized.

Outcome measures

Outcome measures
Measure
Observational (Respond to Surveys, Medical Record Review)
n=175 Participants
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks. Medical Chart Review: Correlative studies Survey Administration: Respond to surveys
Information on the Treatment for Cancers Diagnosed in HIV-positive Individuals
Surgery only
3 Participants
Information on the Treatment for Cancers Diagnosed in HIV-positive Individuals
surgery and chemotherapy
2 Participants
Information on the Treatment for Cancers Diagnosed in HIV-positive Individuals
Radiation only
2 Participants
Information on the Treatment for Cancers Diagnosed in HIV-positive Individuals
Radiation and chemotherapy
3 Participants
Information on the Treatment for Cancers Diagnosed in HIV-positive Individuals
Chemotherapy only
24 Participants
Information on the Treatment for Cancers Diagnosed in HIV-positive Individuals
Chemotherapy and other
1 Participants
Information on the Treatment for Cancers Diagnosed in HIV-positive Individuals
Other
11 Participants
Information on the Treatment for Cancers Diagnosed in HIV-positive Individuals
No information
129 Participants

SECONDARY outcome

Timeframe: Baseline

Population: 1 missing CD4 value

CD4 percent of HIV-positive Individuals Diagnosed With Cancer will be summarized.

Outcome measures

Outcome measures
Measure
Observational (Respond to Surveys, Medical Record Review)
n=174 Participants
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks. Medical Chart Review: Correlative studies Survey Administration: Respond to surveys
CD4 of HIV-positive Individuals Diagnosed With Cancer
Kaposi sarcoma
15 Percentage of CD4 cells
Interval 8.0 to 22.0
CD4 of HIV-positive Individuals Diagnosed With Cancer
Non-Hodgkin's lymphoma
14.5 Percentage of CD4 cells
Interval 9.0 to 25.0
CD4 of HIV-positive Individuals Diagnosed With Cancer
Hodgkin's lymphoma
17 Percentage of CD4 cells
Interval 16.0 to 24.0
CD4 of HIV-positive Individuals Diagnosed With Cancer
Anal
18 Percentage of CD4 cells
Interval 13.0 to 24.0
CD4 of HIV-positive Individuals Diagnosed With Cancer
Cervical
18 Percentage of CD4 cells
Interval 16.0 to 24.0
CD4 of HIV-positive Individuals Diagnosed With Cancer
Other
26 Percentage of CD4 cells
Interval 18.0 to 35.0

SECONDARY outcome

Timeframe: Baseline

Population: 89 participants were assessed for this Outcome Measure.

HIV viral load of HIV-positive Individuals Diagnosed With Cancer will be summarized

Outcome measures

Outcome measures
Measure
Observational (Respond to Surveys, Medical Record Review)
n=89 Participants
Patients respond to surveys and/or undergo medical record review at baseline and at 4 weeks. Medical Chart Review: Correlative studies Survey Administration: Respond to surveys
HIV Viral Load of HIV-positive Individuals Diagnosed With Cancer
Anal
30 copies per ml
Interval 20.0 to 40.0
HIV Viral Load of HIV-positive Individuals Diagnosed With Cancer
Cervical
40.5 copies per ml
Interval 40.0 to 41.0
HIV Viral Load of HIV-positive Individuals Diagnosed With Cancer
Other
40 copies per ml
Interval 40.0 to 47.0
HIV Viral Load of HIV-positive Individuals Diagnosed With Cancer
Kaposi sarcoma
46 copies per ml
Interval 40.0 to 1125.0
HIV Viral Load of HIV-positive Individuals Diagnosed With Cancer
Non-Hodgkin's lymphoma
40.5 copies per ml
Interval 40.0 to 29246.0
HIV Viral Load of HIV-positive Individuals Diagnosed With Cancer
Hodgkin's lymphoma49
49 copies per ml
Interval 40.0 to 364.0

Adverse Events

Observational (Respond to Surveys, Medical Record Review)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Deukwoo Kwon

Statistical and Data Analysis Center, AIDS Malignancy Consortium

Phone: (713) 500-7964

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place