An observational study in Covid19 and Genito Urinary Cancer, sponsored by Spanish Oncology Genito-Urinary Group. Completed at 32 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by Spanish Oncology Genito-Urinary Group · 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.
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:
Pathological history:
Concomitant pathology Usual drug treatment
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
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
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
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 410 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Spanish Oncology Genito-Urinary Group is the lead sponsor of 30 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
Exclusion Criteria:
Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered from COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
Age at Baseline
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
Time frame: Baseline, at the time of inclusion
Frequency of Complications of COVID-19 Intercurrent Infection
Percentage of patients with complications associated to COVID-19 infection (classified by type and severity)
Time frame: Through study completion, average 1 year
Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by 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.
Time frame: Through study completion, average 1 year
Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment
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
Time frame: Through study completion, average 1 year
Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy)
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.
Time frame: Through study completion, average 1 year
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.
Time frame: Through study completion, average 1 year. Measured at 3 scenarios (during treatment, after treatment and therapies indicated after infection has passed)
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.
Time frame: Through study completion, average 1 year
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.
Time frame: Through study completion, average 1 year
Asymptomatic Rate
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
Time frame: Through study completion, average 1 year
Asymptomatic Rate in Renal Cancer
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
Time frame: Through study completion, average 1 year
Asymptomatic Rate in Urothelial Cancer
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
Time frame: Through study completion, average 1 year
Asymptomatic Rate in Prostate Cancer
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections
Time frame: Through study completion, average 1 year
Asymptomatic Rate in Testicular Cancer
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections
Time frame: Through study completion, average 1 year
Frequency of Delays/Modifications on Cancer Treatment Schedule
delays / modifications in cancer follow-up or treatment regimens.
Time frame: Through study completion, average 1 year
Progression Free Survival in Patients With Genitourinary Tumors That Suffered COVID-19, Patients With a First Line Treatment Ongoing at the Moment of COVID Infection
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. PROGRESSION FREE SURVIVAL (FIRST LINE IN METASTATIC OR ADVANCED SETTING) The date of treatment start (treatment ongoing at the moment of COVID infection) is taken as the start date of follow-up. Only patients with a first line treatment ongoing at the moment of COVID infection were analyzed.
Time frame: From start of treatment until progression or death, up to 130 months
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. For the calculation of overall survival, it is taken from the date of cancer diagnosis to the date of death (at any time, not only in a prospective part).
Time frame: From start of treatment until progression or death, up to 130 months
| Milestone | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| Started | 410 |
| Completed | 410 |
| Not completed | 0 |
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
| years | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| Age at Baseline | 70 (17 to 100) |
Percentage of patients with complications associated to COVID-19 infection (classified by type and severity)
| Participants | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| Death secondary to infectioninfection | 73 |
| ICU admission due to need of symptom control | 5 |
| Hospital admission due to need of symptom control | 136 |
| Need for mechanical ventilation | 3 |
| No complications. Common infection at home | 191 |
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.
| Participants | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| Immunotherapy treatment/no Pneumonia | 51 |
| Immunotherapy treatment/ Pneumonia | 36 |
| No Immunotherapy treatment/no Pneumonia | 181 |
| No Immunotherapy treatment/Pneumonia | 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
| Participants | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| Corticosteroid treatment/ no Pneumonia | 59 |
| Corticosteroid treatment/ si Pneumonia | 55 |
| No Corticosteroid treatment/ no Pneumonia | 173 |
| No Corticosteroid treatment/ si Pneumonia | 120 |
| UK | 1 |
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.
| Participants | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| Immunotherapy treatment /no complications | 45 |
| Immunotherapy treatment /admissions | 31 |
| Immunotherapy treatment /Death secondary to infection | 11 |
| No Immunotherapy treatment /no complications | 146 |
| No Immunotherapy treatment /admissions | 113 |
| No Immunotherapy treatment /Death secondary to infection | 62 |
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.
| Participants | Patients Diagnosed With Genitourinary Cancer Hat Suffered COVID-19 Treatment With Immunotherapy |
|---|---|
| Arthritis G1 | 1 |
| Arthritis G3 | 1 |
| Colitis G1 | 1 |
| Colitis G2 | 1 |
| Colitis G3 | 1 |
| Hepatitis G2 | 3 |
| Hepatitis G3 | 3 |
| Hepatitis G4 | 1 |
| Hypophysitis G2 | 1 |
| Nephritis G1 | 1 |
| Nephritis G2 | 1 |
| Nephritis G3 | 1 |
| Nephritis G4 | 1 |
| Pneumonitis G2 | 1 |
| Thyroiditis G1 | 2 |
| Thyroiditis G2 | 2 |
To assess the mortality associated with COVID-19 infection in the population with genitourinary tumors. Percentage of patients alive / dead at discharge.
| Participants | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| Alive | 137 |
| Dead | 80 |
| NA | 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.
| Participants | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| Death secondary to infection | 73 |
| ICU admission due to need of symptom control | 5 |
| Hospital admission due to need of symptom control | 136 |
| Need for mechanical ventilation | 3 |
| No complications. Common infection at home | 191 |
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
| Participants | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| symptomatic | 308 |
| Asymptomatic | 100 |
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
| Participants | Renal Cancer Patients That Suffered COVID-19 |
|---|---|
| Symptomatic | 63 |
| Asymptomatic | 27 |
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
| Participants | Urothelial Cancer Patients That Suffered COVID-19 |
|---|---|
| Asymptomatic | 32 |
| Symptomatic | 96 |
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections
| Participants | Prostate Cancer Patients That Suffered COVID-19 |
|---|---|
| Asymptomatic | 33 |
| Symptomatic | 133 |
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections
| Participants | Testicular Cancer Patients That Suffered COVID-19 |
|---|---|
| asymptomatic | 6 |
| symptomatic | 15 |
delays / modifications in cancer follow-up or treatment regimens.
| Participants | Patients With Genitourinary Tumor Presenting Covid-19 Infection With Prospective Part |
|---|---|
| Start Treatment after COVID-19 | 20 |
| Restart Treatment after COVID-19 | 146 |
| With treatment after COVID-19 without specifying start/restart | 6 |
| Without oncology treatment after COVID-19 (reported) | 154 |
delays / modifications in cancer follow-up or treatment regimens.
| Participants | Patients With Genitourinary Tumor Presenting Covid-19 Infection With Prospective Part |
|---|---|
| Dose | 1 |
| Change in administration schedule | 15 |
| Temporary suspension of treatment | 22 |
delays / modifications in cancer follow-up or treatment regimens.
| Participants | Patients With Genitourinary Tumor Presenting Covid-19 Infection With Prospective Part |
|---|---|
| Yes Treatment modification (prospective visit) | 38 |
| No Treatment modification (prospective visit) | 108 |
| New treatment o no treatment start date | 24 |
| NA/UK | 156 |
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. PROGRESSION FREE SURVIVAL (FIRST LINE IN METASTATIC OR ADVANCED SETTING) The date of treatment start (treatment ongoing at the moment of COVID infection) is taken as the start date of follow-up. Only patients with a first line treatment ongoing at the moment of COVID infection were analyzed.
| months | Genitourinary Cancer Patients With a First Line Treatment Ongoing at the Moment of COVID Infection. |
|---|---|
| Renal | 93.26 (45.62 to 140.91) |
| Urothelial | 80.13 (28.38 to 131.88) |
| Prostate | 121.94 (96.68 to 147.2) |
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. For the calculation of overall survival, it is taken from the date of cancer diagnosis to the date of death (at any time, not only in a prospective part).
| years | Patients With Genitourinary Tumor Presenting Covid-19 Infection With Prospective Part |
|---|---|
| Renal | 18.36 (14.51 to 22.22) |
| Urothelial | 7.03 (4.91 to 9.14) |
| Prostate | 11.49 (9.85 to 13.13) |
| Testicular | 24.37 (19.97 to 28.76) |
Collected over 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). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adverse Events | 152/408 (37.3%) | 0/87 (0%) | 22/87 (25.3%) |
| Event | Adverse Events |
|---|---|
| HepatitisHepatobiliary disorders | 7/87 |
| NephritisGeneral disorders | 4/87 |
| ThyroiditisEndocrine disorders | 4/87 |
| ColitisInfections and infestations | 3/87 |
| ArthritisGeneral disorders | 2/87 |
| PneumonitisInfections and infestations | 1/87 |
| HypophysitisEndocrine disorders | 1/87 |
| Age, Continuous(years) | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| Median | 70 (17 to 100) |
| Sex: Female, Male(Participants) | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| Female | 51 |
| Male | 357 |
| Race (NIH/OMB)(Participants) | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 408 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Smoking status(Participants) | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| Never | 136 |
| Ever | 231 |
| UK | 41 |
| Comorbities(Participants) | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| Hypertension | 224 |
| Diabetes | 92 |
| Cardiopathy | 79 |
| COPD / Asma | 57 |
| Hepatopathy | 19 |
| Nephropathy | 53 |
| None | 121 |
| Cancer type(Participants) | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| Prostate | 166 |
| Urothelial | 128 |
| Kidney | 90 |
| Testicular | 23 |
| Penile | 1 |
| Clinical cancer stage at cancer diagnosis;(Participants) | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| 0 | 2 |
| I | 54 |
| II | 64 |
| III | 90 |
| IV | 166 |
| UK | 32 |
| Time from cancer diagnosis to SARS-CoV-2 infection(months) | Genitourinary Cancer Patients That Suffered COVID-19 |
|---|---|
| Median | 32 (27 to 38) |
4 further baseline measures are reported on the registry.
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Plan to share: No
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Spanish Oncology Genito-Urinary Group