Description of the Population With Genitourinary Tumors and COVID-19

NCT ID: NCT04578132

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 410 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-18
• Study Completion Date: 2022-11-23

Brief Summary

The identification of patients with genitourinary tumors who suffer from the infection by the Serious Acute Respiratory Syndrome Corona-Virus 2 (SARS-CoV-2) virus can represent multiple benefits both for themselves and for health professionals and the health system itself. We would be able to know more precisely the clinical evolution of these type of patient, to know their prognosis and being capable to select the most appropriate treatment modality for future pandemics.

SOGUG-COVID is an observational prospective-retrospective trial purely epidemiological, that aims to describe the population with genitourinary tumors (urothelial cancer, prostate cancer, testicular cancer and kidney cancer) infected by COrona VIrus Disease 19 (COVID-19) treated in Spanish hospitals, learn about the clinical presentation, therapeutic evolution and prognosis of said intercurrent infectious process, as well as its possible relationship with different clinical and therapeutic factors.

Detailed Description

The study will be carried out in Spanish hospitals, with principal investigators belonging to the medical oncology services of the SOGUG group (Spanish Group of Genitourinary Oncology), who will act as promoter. Once the patients have been selected, the variables of interest will be collected and studied. The main variables to record will be:

1. Patient characteristics

2. Hospital center where the patient is recruited

3. Pathological history:

Concomitant pathology Usual drug treatment

4. Tumor pathology:

Tumor type, histology, and stage (initial and at diagnosis of infection) Cancer diagnosis date Active cancer treatment or follow-up Participation in clinical trial Type of treatment most recently received for the infection (Surgery; Radiotherapy; Chemotherapy, Immunotherapy ...) Treatment lines, initiation and last dose received of the most recent most recent cancer treatment

5. COVID-19 infection:

Confirmation date of COVID-19 infection PCR (Polymerase Chain Reaction) diagnostic test Immunoglobulin G (IgG) or Immunoglobulin M (IgM) serological diagnostic test Present symptoms, analytical alterations, thrombosis associated with COVID-19 infection, complications of infection Date of onset and disappearance of symptoms Days of fever and cough Radiological examination at the time of greatest severity Treatments received for COVID-19 Status upon discharge Date of discharge / exitus Negative presence of virus by PCR and PCR date

6. For patients who are receiving or have received immunotherapy treatments, additional information will be collected:

Immunotherapy treatment line and type Start / end date and last dose previous infection of the treatment with immunotherapy Adverse effects

7. Prospective follow-up data (6 months from patient inclusion):

Date of start or restart of cancer treatment after infection Change / suspension of cancer treatment after COVID-19 Date of surgery in neoadjuvant patients Recurrence of COVID-19 Best response obtained Date of progression to cancer treatment Current status and date of last contact The study will use the data obtained from the patient's medical history, with no plans to use other sources.

The assignment of a patient to a specific therapeutic strategy has already been decided in advance by the usual clinical practice of medicine; The decision to prescribe a specific treatment is clearly dissociated from the decision to include a patient in the study. No intervention will be applied to patients, whether diagnostic or follow-up, that is not the usual clinical practice. Epidemiological methods will be used to analyze the collected data.

Conditions

Covid19; Genito Urinary Cancer

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: OTHER

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients ≥18 years old.
• Diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ).
• COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
• The COVID-19 infection must be confirmed by PCR or serology, regardless of whether or not the patient requires hospitalization for the infection, additionally, a clinical and / or radiological determination must be available in those patients who present symptoms.

Exclusion Criteria

• Not applicable

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Oncology Genito-Urinary Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miguel Ángel Climent, M.D., Ph.D.

Role: STUDY_CHAIR

Instituto Valenciano de Oncología

Javier Puente, M.D., Ph.D.

Role: STUDY_CHAIR

Hospital Clínico San Carlos de Madrid

Aránzazu González del Alba, M.D., Ph.D.

Role: STUDY_CHAIR

Hospital Universitario Puerta de Hierro-Majadahonda

Sergio Vázquez Estevez, M.D., Ph.D.

Role: STUDY_CHAIR

Hospital Universitario Lucus Augusti

Natalia Vidal, M.D., Ph.D.

Role: STUDY_CHAIR

Hospital Clínico San Carlos de Madrid

Locations

Institut Català d'Oncologia L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Althaia

Manresa, Barcelona, Spain

Hospital Universitari Parc Taulí

Sabadell, Barcelona, Spain

Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda, Madrid, Spain

Hospital Universitario de Badajoz

Badajoz, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario Vall d Hebron

Barcelona, , Spain

Hospital Universitario de Burgos

Burgos, , Spain

Hospital de Ciudad Real

Ciudad Real, , Spain

Hospital Universitario Reina Sofía

Córdoba, , Spain

Instituto Catalán de Oncología- Girona

Girona, , Spain

Hospital Universitario Lucus Augusti

Lugo, , Spain

Fundación Jiménez Díaz

Madrid, , Spain

Hospital 12 de Octubre

Madrid, , Spain

Hospital Clínico San Carlos de Madrid

Madrid, , Spain

Hospital Infanta Leonor,

Madrid, , Spain

Hospital Universitario Gregorio Marañón

Madrid, , Spain

Hospital Universitario HM Sanchinarro

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario La Princesa

Madrid, , Spain

Hospital Universitario Quironsalud

Madrid, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Complejo Hospitalario Universitario Ourense

Ourense, , Spain

Clinica Universidad de Navarra

Pamplona, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Hospital Nuestra Señora del Prado

Talavera de la Reina, , Spain

Hospital Virgen de la Salud

Toledo, , Spain

Hospital Universitario Dr. Peset

Valencia, , Spain

Instituto Valenciano de Oncología

Valencia, , Spain

Hospital Txagorritxu

Vitoria-Gasteiz, , Spain

Hospital Miguel Servet

Zaragoza, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SOG-INM-2020-04

Identifier Type: -

Identifier Source: org_study_id