Description of the Population With Genitourinary Tumors and COVID-19

Covid19 Clinical Trial

— SOGUGCOVID  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04578132
• Other study ID #: SOG-INM-2020-04
• Status: Active, not recruiting
• Start date: November 24, 2020
• Est. completion date: October 2022

Study information

• Verified date: March 2021
• Source: Spanish Oncology Genito-Urinary Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 408
• Est. completion date: October 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Genito Urinary Cancer
• Urogenital Neoplasms

Locations

Country	Name	City	State
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	Institut Català d'Oncologia L'Hospitalet	Hospitalet de Llobregat	Barcelona
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	Hospital Universitario Puerta de Hierro-Majadahonda	Majadahonda	Madrid
Spain	Althaia	Manresa	Barcelona
Spain	Complejo Hospitalario Universitario Ourense	Orense
Spain	Clinica Universidad de Navarra	Pamplona
Spain	Hospital Universitari Parc Taulí	Sabadell	Barcelona
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

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Oncology Genito-Urinary Group

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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	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
Secondary	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
Secondary	Asymptomatic rate	Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.	Through study completion, average 1 year
Secondary	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
Secondary	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
Secondary	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