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Description of the Population With Genitourinary Tumors and COVID-19
trial in Covid19 in 410 participants. Completed in 23 November 2022.
| Lead sponsor | Spanish Oncology Genito-Urinary Group |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 410 |
| Start date | 18 December 2020 |
| Primary completion | 23 November 2022 |
| Estimated completion | 23 November 2022 |
| Sites | 32 locations across Spain |
Spanish Oncology Genito-Urinary Group — full company profile →
18 and older, any sex, with Covid19 or Genito Urinary Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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: Spcifically here we reported the Age
| Group | Value | 95% CI |
|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | 70 | 17 – 100 |
Percentage of patients with complications associated to COVID-19 infection (classified by type and severity)
| Group | Value | 95% CI |
|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | 73 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 5 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 136 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 3 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | 51 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 36 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 181 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 140 |
To evaluate in patients with Genitourinary Cancer 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
| Group | Value | 95% CI |
|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | 59 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 55 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 173 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 120 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | 45 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 31 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 11 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 146 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Patients Diagnosed With Genitourinary Cancer Hat Suffered COVID-19 Treatment With Immunotherapy | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Patients Diagnosed With Genitourinary Cancer Hat Suffered COVID-19 Treatment With Immunotherapy | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Patients Diagnosed With Genitourinary Cancer Hat Suffered COVID-19 Treatment With Immunotherapy | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Patients Diagnosed With Genitourinary Cancer Hat Suffered COVID-19 Treatment With Immunotherapy | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Patients Diagnosed With Genitourinary Cancer Hat Suffered COVID-19 Treatment With Immunotherapy | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Patients Diagnosed With Genitourinary Cancer Hat Suffered COVID-19 Treatment With Immunotherapy | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Patients Diagnosed With Genitourinary Cancer Hat Suffered COVID-19 Treatment With Immunotherapy | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Patients Diagnosed With Genitourinary Cancer Hat Suffered COVID-19 Treatment With Immunotherapy | 1 |
To assess the mortality associated with COVID-19 infection in the population with genitourinary tumors. Percentage of patients alive / dead at discharge.
| Group | Value | 95% CI |
|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | 137 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 80 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 191 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | 73 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 5 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 136 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 3 |
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
| Group | Value | 95% CI |
|---|---|---|
| Genitourinary Cancer Patients That Suffered COVID-19 | 308 | |
| Genitourinary Cancer Patients That Suffered COVID-19 | 100 |
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
| Group | Value | 95% CI |
|---|---|---|
| Renal Cancer Patients That Suffered COVID-19 | 63 | |
| Renal Cancer Patients That Suffered COVID-19 | 27 |
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
| Group | Value | 95% CI |
|---|---|---|
| Urothelial Cancer Patients That Suffered COVID-19 | 32 | |
| Urothelial Cancer Patients That Suffered COVID-19 | 96 |
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections
| Group | Value | 95% CI |
|---|---|---|
| Prostate Cancer Patients That Suffered COVID-19 | 33 | |
| Prostate Cancer Patients That Suffered COVID-19 | 133 |
Time frame: 2 year Note: Adverse events were only collected and reported by those patients on active immunotherapy by the time of SARS-CoV-2 infection (n=87). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Adverse Events |
|---|---|---|
| Hepatitis | Hepatobiliary disorders | — |
| Nephritis | General disorders | — |
| Thyroiditis | Endocrine disorders | — |
| Colitis | Infections and infestations | — |
| Arthritis | General disorders | — |
| Pneumonitis | Infections and infestations | — |
| Hypophysitis | Endocrine disorders | — |
Data from ClinicalTrials.gov NCT04578132 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04578132.
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