Description of the Population With Genitourinary Tumors and COVID-19 (SOGUGCOVID)

Observational Retrospective-prospective Study in Patients With Genitourinary Tumors Presenting COVID-19 Infection (SOGUG-COVID-19)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19; Genito Urinary Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 408

Contacts and Locations

Study Locations

• Spain
  • Badajoz, Spain
    • Hospital Universitario de Badajoz
  • Barcelona, Spain
    • Hospital del Mar
  • Barcelona, Spain
    • Hospital Universitario Vall d Hebron
  • Barcelona, Spain
    • Hospital Santa Creu i Sant Pau
  • Burgos, Spain
    • Hospital Universitario de Burgos
  • Ciudad Real, Spain
    • Hospital de Ciudad Real
  • Córdoba, Spain
    • Hospital Universitario Reina Sofía
  • Girona, Spain
    • Instituto Catalán de Oncología- Girona
  • Lugo, Spain
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain
    • Hospital Clínico San Carlos de Madrid
  • Madrid, Spain
    • Hospital 12 de Octubre
  • Madrid, Spain
    • Fundacion Jimenez Diaz
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain
    • Hospital Universitario La Princesa
  • Madrid, Spain
    • Hospital Universitario Gregorio Marañon
  • Madrid, Spain
    • Hospital Universitario HM Sanchinarro
  • Madrid, Spain
    • Hospital Universitario Quirónsalud
  • Madrid, Spain
    • Hospital Infanta Leonor,
  • Orense, Spain
    • Complejo Hospitalario Universitario Ourense
  • Pamplona, Spain
    • Clinica Universidad de Navarra
  • Sevilla, Spain
    • Hospital Universitario Virgen Macarena
  • Talavera De La Reina, Spain
    • Hospital Nuestra Señora del Prado
  • Toledo, Spain
    • Hospital Virgen De La Salud
  • Valencia, Spain
    • Instituto Valenciano de Oncologia
  • Valencia, Spain
    • Hospital Universitario Dr. Peset
  • Vitoria, Spain
    • Hospital Txagorritxu
  • Zaragoza, Spain
    • Hospital Miguel Servet
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain
      • Institut Catala d'Oncologia L'Hospitalet
    • Manresa, Barcelona, Spain
      • Althaia
    • Sabadell, Barcelona, Spain
      • Hospital Universitari Parc Tauli
  • Madrid
    • Majadahonda, Madrid, Spain
      • Hospital Universitario Puerta de Hierro-Majadahonda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline characteristics	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: Age, gender, cancer type. Categorical variables will be presented as counts and percentages.	Through study completion, average 1 year
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 in patients stratified by oncological 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 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)
Frequency of complications of COVID-19 infection in patients with prostate cancer stratified by anti-androgenic oncological treatment	To evaluate in patients with Prostate Cancer (PCa) 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 mortality rate in patients with genitourinary cancer	To assess the mortality associated with COVID-19 infection in the population with genitourinary tumors. Percentage of patients alive / dead at discharge.	Through study completion, average 1 year
COVID-19 complication rate in patients with genitourinary cancer	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.	Through study completion, average 1 year
Asymptomatic rate	Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.	Through study completion, average 1 year
Frequency of delays/modifications on cancer treatment schedule	delays / modifications in cancer follow-up or treatment regimens. The average delay time and the number of modifications will be evaluated.	Through study completion, average 1 year
Progression free survival in patients with genitourinary tumors that suffered COVID-19	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	Through study completion, average 1 year
Overall survival in patients with genitourinary tumors that suffered COVID-19	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	Through study completion, average 1 year

Collaborators and Investigators

• Sponsor: Spanish Oncology Genito-Urinary Group
• Investigators: Study Chair: Miguel Ángel Climent, M.D., Ph.D., Instituto Valenciano de Oncologia; 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 record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: prostate cancer; COVID-19; Kidney cancer; Urothelial cancer; Germ line cancer
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Pneumonia, Viral; Pneumonia; Lung Diseases; Neoplasms by Site; COVID-19; Urogenital Neoplasms
• Other Study ID Numbers: SOG-INM-2020-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No