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

Unknown status
COVID19
Genito Urinary Cancer
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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Spain
Locations

Institut Català d'Oncologia L'Hospitalet
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
Orense, Spain

Clinica Universidad de Navarra
Pamplona, Spain

Hospital Universitario Virgen Macarena
Sevilla, 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, Spain

Hospital Miguel Servet
Zaragoza, Spain

Spanish Oncology Genito-Urinary Group
NCT Number
Keywords
Urothelial cancer
prostate cancer
Germ line cancer
Kidney cancer
Covid-19
MeSH Terms
COVID-19
Urogenital Neoplasms