Covid19SOGUGCOVIDNCT04578132
Description of the Population With Genitourinary Tumors and COVID-19
An observational study of Covid19 and Genito Urinary Cancer, run by Spanish Oncology Genito-Urinary Group at 32 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Genito Urinary Cancer
- How many people
- 410 participants
- Where
- 32 sitesSpain
- Study dates
- 18 Dec 2020to 23 Nov 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
Who may be able to join
- 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.
Who cannot join
- Not applicable
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Spain32 sites
Hospital Universitario de Badajoz
Badajoz
Hospital del Mar
Barcelona
Hospital Santa Creu i Sant Pau
Barcelona
Hospital Universitario Vall d Hebron
Barcelona
Hospital Universitario de Burgos
Burgos
Hospital de Ciudad Real
Ciudad Real
Hospital Universitario Reina Sofía
Córdoba
Instituto Catalán de Oncología- Girona
Girona
Institut Català d'Oncologia L'Hospitalet
L'Hospitalet de Llobregat, Barcelona
Hospital Universitario Lucus Augusti
Lugo
Fundación Jiménez Díaz
Madrid
Hospital 12 de Octubre
Madrid
Hospital Clínico San Carlos de Madrid
Madrid
Hospital Infanta Leonor,
Madrid
Hospital Universitario Gregorio Marañón
Madrid
Hospital Universitario HM Sanchinarro
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario La Princesa
Madrid
Hospital Universitario Quironsalud
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid
Althaia
Manresa, Barcelona
Complejo Hospitalario Universitario Ourense
Ourense
Clinica Universidad de Navarra
Pamplona
Hospital Universitari Parc Taulí
Sabadell, Barcelona
Hospital Universitario Virgen Macarena
Seville
Hospital Nuestra Señora del Prado
Talavera de la Reina
Hospital Virgen de la Salud
Toledo
Hospital Universitario Dr. Peset
Valencia
Instituto Valenciano de Oncología
Valencia
Hospital Txagorritxu
Vitoria-Gasteiz
Hospital Miguel Servet
Zaragoza
About this study
Official title: Observational Retrospective-prospective Study in Patients With Genitourinary Tumors Presenting COVID-19 Infection (SOGUG-COVID-19)
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.
Read the 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:
- Patient characteristics
- Hospital center where the patient is recruited
- 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
- 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
- Keywords
- Urothelial cancer, prostate cancer, Germ line cancer, Kidney cancer, COVID-19
- Medical subject headings
- COVID-19, Urogenital Neoplasms, Prostatic Neoplasms, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Genitourinary cancer patients that suffered COVID-19 | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Through study completion, average 1 year. Measured at 3 scenarios (during treatment, after treatment and therapies indicated after infection has passed)
Secondary outcomes (10)
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.
Measured: 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.
Measured: Through study completion, average 1 year
Asymptomatic Rate
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
Measured: Through study completion, average 1 year
Asymptomatic Rate in Renal Cancer
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
Measured: Through study completion, average 1 year
Asymptomatic Rate in Urothelial Cancer
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
Measured: Through study completion, average 1 year
Asymptomatic Rate in Prostate Cancer
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections
Measured: Through study completion, average 1 year
Asymptomatic Rate in Testicular Cancer
Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections
Measured: Through study completion, average 1 year
Frequency of Delays/Modifications on Cancer Treatment Schedule
delays / modifications in cancer follow-up or treatment regimens.
Measured: 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.
Measured: 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).
Measured: From start of treatment until progression or death, up to 130 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start18 Dec 2020
- Primary completion23 Nov 2022
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Oncology Genito-Urinary Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miguel Ángel Climent, M.D., Ph.D., Study chair, Instituto Valenciano de OncologíaJavier Puente, M.D., Ph.D., Study chair, Hospital Clínico San Carlos de MadridAránzazu González del Alba, M.D., Ph.D., Study chair, Hospital Universitario Puerta de Hierro MajadahondaSergio Vázquez Estevez, M.D., Ph.D., Study chair, Hospital Universitario Lucus AugustiNatalia Vidal, M.D., Ph.D., Study chair, Hospital Clínico San Carlos de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578132
- Sponsor's protocol ID
- SOG-INM-2020-04
- Acronym
- SOGUGCOVID
- Status last verified
- Mar 2021
- First submitted
- 6 Oct 2020
- Last updated
- 1 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective-prospective Study in Patients With Genitourinary Tumors Presenting COVID-19 Infection (SOGUG-COVID-19)
- ClinicalTrials.gov ID
- NCT04578132
- Acronym / sponsor ID
- SOGUGCOVID / SOG-INM-2020-04
- Conditions
- Covid19, Genito Urinary Cancer
- Keywords
- Urothelial cancer, prostate cancer, Germ line cancer, Kidney cancer, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Spanish Oncology Genito-Urinary GroupUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Posted 1 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patient characteristics
- Hospital center where the patient is recruited
- 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
- 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genitourinary cancer patients that suffered COVID-19 | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with genitourinary cancer (urothelial, kidney, prostate and germ) that suffered COVID-19 infection prior to cancer treatment, during treatment, or after treatment.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Age at Baseline
Time frame: Baseline, at the time of inclusion
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
Frequency of Complications of COVID-19 Intercurrent Infection
Time frame: Through study completion, average 1 year
Percentage of patients with complications associated to COVID-19 infection (classified by type and severity)
Frequency of Complications of COVID-19 Infection (Pneumonia) Stratified by Treatment
Time frame: Through study completion, average 1 year
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.
Frequency of Complications of COVID-19 Infection in Patients With Genitourinary Cancer Stratified by Anti-androgenic Oncological Treatment
Time frame: Through study completion, average 1 year
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
Frequency of Complications of COVID-19 Infection Stratified by Treatment (Immunotherapy vs no Immunotherapy)
Time frame: Through study completion, average 1 year
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.
Frequency of Adverse Events Related to Immunotherapy Targeted to Cancer (Classified by Type and Severity)
Time frame: Through study completion, average 1 year. Measured at 3 scenarios (during treatment, after treatment and therapies indicated after infection has passed)
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.
10 secondary outcomes
COVID-19 Mortality Rate in Patients With Genitourinary Cancer
Time frame: Through study completion, average 1 year
COVID-19 Complication Rate in Patients With Genitourinary Cancer
Time frame: Through study completion, average 1 year
Asymptomatic Rate
Time frame: Through study completion, average 1 year
Asymptomatic Rate in Renal Cancer
Time frame: Through study completion, average 1 year
Asymptomatic Rate in Urothelial Cancer
Time frame: Through study completion, average 1 year
Asymptomatic Rate in Prostate Cancer
Time frame: Through study completion, average 1 year
Asymptomatic Rate in Testicular Cancer
Time frame: Through study completion, average 1 year
Frequency of Delays/Modifications on Cancer Treatment Schedule
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
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
Time frame: From start of treatment until progression or death, up to 130 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Ángel Climent, M.D., Ph.D. study chair
Instituto Valenciano de Oncología
Javier Puente, M.D., Ph.D. study chair
Hospital Clínico San Carlos de Madrid
Aránzazu González del Alba, M.D., Ph.D. study chair
Hospital Universitario Puerta de Hierro Majadahonda
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Genito Urinary Cancer, run by Spanish Oncology Genito-Urinary Group at 32 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age at Baseline (time frame: Baseline, at the time of inclusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.