Description of the Population With Genitourinary Tumors and COVID-19

NCT04578132 | Completed Results DMC

• 1 other identifier: SOG-INM-2020-04
• Study Type: observational
• Target: 410
• Locations: 1 country
• Sites: 32

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.

Conditions

Covid19; Genito Urinary Cancer

Keywords

Urothelial cancer; prostate cancer; Germ line cancer; Kidney cancer; COVID-19

Outcome Measures

Primary Outcomes (6)

• Age at Baseline

  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

  Baseline, at the time of inclusion

• Frequency of Complications of COVID-19 Intercurrent Infection

  Percentage of patients with complications associated to COVID-19 infection (classified by type and severity)

  Through study completion, average 1 year

• Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by Treatment

  To 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.

  Through study completion, average 1 year

• Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment

  To 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

  Through study completion, average 1 year

• Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy)

  To 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.

  Through study completion, average 1 year

• Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)

  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.

  Through study completion, average 1 year. Measured at 3 scenarios (during treatment, after treatment and therapies indicated after infection has passed)

Secondary Outcomes (10)

• COVID-19 Mortality Rate in Patients With Genitourinary Cancer

  Through study completion, average 1 year

• COVID-19 Complication Rate in Patients With Genitourinary Cancer

  Through study completion, average 1 year

• Asymptomatic Rate

  Through study completion, average 1 year

• Asymptomatic Rate in Renal Cancer

  Through study completion, average 1 year

• Asymptomatic Rate in Urothelial Cancer

  Through study completion, average 1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered COVID-19 infection prior to cancer treatment, during treatment, or after treatment.

You may qualify if:

• 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.

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Spanish Oncology Genito-Urinary Group: lead

Study Sites (32)

Institut Català d'Oncologia L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Althaia

Manresa, Barcelona, Spain

Location

Hospital Universitari Parc Taulí

Sabadell, Barcelona, Spain

Location

Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda, Madrid, Spain

Location

Hospital Universitario de Badajoz

Badajoz, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Universitario Vall d Hebron

Barcelona, Spain

Location

Hospital Universitario de Burgos

Burgos, Spain

Location

Hospital de Ciudad Real

Ciudad Real, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Instituto Catalán de Oncología- Girona

Girona, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, Spain

Location

Fundación Jiménez Díaz

Madrid, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Hospital Clínico San Carlos de Madrid

Madrid, Spain

Location

Hospital Infanta Leonor,

Madrid, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario La Princesa

Madrid, Spain

Location

Hospital Universitario Quironsalud

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Complejo Hospitalario Universitario Ourense

Ourense, Spain

Location

Clinica Universidad de Navarra

Pamplona, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

Hospital Nuestra Señora del Prado

Talavera de la Reina, Spain

Location

Hospital Virgen de la Salud

Toledo, Spain

Location

Hospital Universitario Dr. Peset

Valencia, Spain

Location

Instituto Valenciano de Oncología

Valencia, Spain

Location

Hospital Txagorritxu

Vitoria-Gasteiz, Spain

Location

Hospital Miguel Servet

Zaragoza, Spain

Location

MeSH Terms

Conditions

COVID-19; Urogenital Neoplasms; Prostatic Neoplasms; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Urologic Neoplasms; Kidney Diseases; Urologic Diseases

Results Point of Contact

• Title: A person designated by the Sponsor
• Organization: An organization designated by the Sponsor

investigacion@mfar.net

+34934344412

Study Officials

• Miguel Ángel Climent, M.D., Ph.D.

  Instituto Valenciano de Oncología

  STUDY CHAIR

• Javier Puente, M.D., Ph.D.

  Hospital Clínico San Carlos de Madrid

  STUDY CHAIR

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

  Hospital Universitario Puerta de Hierro-Majadahonda

  STUDY CHAIR

• Sergio Vázquez Estevez, M.D., Ph.D.

  Hospital Universitario Lucus Augusti

  STUDY CHAIR

• Natalia Vidal, M.D., Ph.D.

  Hospital Clínico San Carlos de Madrid

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 8, 2020
• Study Start: December 18, 2020
• Primary Completion: November 23, 2022
• Study Completion: November 23, 2022
• Last Updated: April 1, 2025
• Results First Posted: April 1, 2025

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (32)