NCT04578132

Description of the Population With Genitourinary Tumors and COVID-19

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 410 (actual)
• Sponsor: Spanish Oncology Genito-Urinary Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19
• Genito Urinary Cancer

Timeline

• Start date: 2020-12-18
• Primary completion: 2022-11-23
• Completion: 2022-11-23
• First posted: 2020-10-08
• Last updated: 2025-04-01
• Results posted: 2025-04-01

Locations

32 sites across 1 country: Spain