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Spots Global Cancer Trial Database for Description of the Population With Genitourinary Tumors and COVID-19

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Trial Identification

Brief Title: Description of the Population With Genitourinary Tumors and COVID-19

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

Study ID: NCT04578132

Interventions

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

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

Contact Details

Name: Miguel Ángel Climent, M.D., Ph.D.

Affiliation: Instituto Valenciano de Oncología

Role: STUDY_CHAIR

Name: Javier Puente, M.D., Ph.D.

Affiliation: Hospital Clínico San Carlos de Madrid

Role: STUDY_CHAIR

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

Affiliation: Hospital Universitario Puerta de Hierro-Majadahonda

Role: STUDY_CHAIR

Name: Sergio Vázquez Estevez, M.D., Ph.D.

Affiliation: Hospital Universitario Lucus Augusti

Role: STUDY_CHAIR

Name: Natalia Vidal, M.D., Ph.D.

Affiliation: Hospital Clínico San Carlos de Madrid

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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