Covid19 Clinical Trial
— SOGUGCOVIDOfficial title:
Observational Retrospective-prospective Study in Patients With Genitourinary Tumors Presenting COVID-19 Infection (SOGUG-COVID-19)
Verified date | March 2021 |
Source | Spanish Oncology Genito-Urinary Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Spanish Oncology Genito-Urinary Group |
Spain,
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 |
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