Description of the Population With Genitourinary Tumors and COVID-19

Completed

Conditions: Covid19
Genito Urinary Cancer

Registration Number: NCT04578132

Lead Sponsor: Spanish Oncology Genito-Urinary Group

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 410

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of Complications of COVID-19 Intercurrent Infection	Through study completion, average 1 year	Percentage of patients with complications associated to COVID-19 infection (classified by type and severity)
Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by Treatment	Through study completion, average 1 year	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.
Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy)	Through study completion, average 1 year	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.
Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment	Through study completion, average 1 year	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
Age at Baseline	Baseline, at the time of inclusion	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
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)	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.

Secondary Outcome Measures

Name	Time	Method
COVID-19 Mortality Rate in Patients With Genitourinary Cancer	Through study completion, average 1 year	To assess the mortality associated with COVID-19 infection in the population with genitourinary tumors. Percentage of patients alive / dead at discharge.
COVID-19 Complication Rate in Patients With Genitourinary Cancer	Through study completion, average 1 year	Evaluate 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.
Asymptomatic Rate	Through study completion, average 1 year	Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
Asymptomatic Rate in Renal Cancer	Through study completion, average 1 year	Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
Asymptomatic Rate in Urothelial Cancer	Through study completion, average 1 year	Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
Asymptomatic Rate in Prostate Cancer	Through study completion, average 1 year	Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections
Asymptomatic Rate in Testicular Cancer	Through study completion, average 1 year	Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections
Frequency of Delays/Modifications on Cancer Treatment Schedule	Through study completion, average 1 year	delays / modifications in cancer follow-up or treatment regimens.
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	From start of treatment until progression or death, up to 130 months	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.
Overall Survival in Patients With Genitourinary Tumors That Suffered COVID-19	From start of treatment until progression or death, up to 130 months	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).

Trial Locations

Locations (32): Hospital Universitario Puerta de Hierro-Majadahonda
🇪🇸
Majadahonda, Madrid, Spain
Hospital del Mar
🇪🇸
Barcelona, Spain
Hospital Universitari Parc Taulí
🇪🇸
Sabadell, Barcelona, Spain
Hospital Santa Creu i Sant Pau
🇪🇸
Barcelona, Spain
Hospital Universitario de Badajoz
🇪🇸
Badajoz, Spain
Hospital Universitario Reina Sofía
🇪🇸
Córdoba, Spain
Hospital de Ciudad Real
🇪🇸
Ciudad Real, Spain
Hospital Universitario Vall d Hebron
🇪🇸
Barcelona, Spain
Hospital Universitario de Burgos
🇪🇸
Burgos, Spain
Instituto Catalán de Oncología- Girona
🇪🇸
Girona, Spain
Fundación Jiménez Díaz
🇪🇸
Madrid, Spain
Hospital Universitario Lucus Augusti
🇪🇸
Lugo, Spain
Hospital 12 de Octubre
🇪🇸
Madrid, Spain
Hospital Universitario Gregorio Marañón
🇪🇸
Madrid, Spain
Hospital Clínico San Carlos de Madrid
🇪🇸
Madrid, Spain
Hospital Infanta Leonor,
🇪🇸
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
Hospital Nuestra Señora del Prado
🇪🇸
Talavera De La Reina, Spain
Complejo Hospitalario Universitario Ourense
🇪🇸
Orense, Spain
Hospital Universitario Dr. Peset
🇪🇸
Valencia, Spain
Hospital Virgen de la Salud
🇪🇸
Toledo, Spain
Clinica Universidad de Navarra
🇪🇸
Pamplona, Spain
Hospital Universitario Virgen Macarena
🇪🇸
Sevilla, Spain
Instituto Valenciano de Oncología
🇪🇸
Valencia, Spain
Hospital Txagorritxu
🇪🇸
Vitoria, Spain
Hospital Miguel Servet
🇪🇸
Zaragoza, Spain
Althaia
🇪🇸
Manresa, Barcelona, Spain
Institut Català d'Oncologia L'Hospitalet
🇪🇸
Hospitalet de Llobregat, Barcelona, Spain