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Trial record 6 of 21 for:    SOGUG

Description of the Population With Genitourinary Tumors and COVID-19 (SOGUGCOVID)

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ClinicalTrials.gov Identifier: NCT04578132
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Spanish Oncology Genito-Urinary Group

Tracking Information
First Submitted Date October 6, 2020
First Posted Date October 8, 2020
Last Update Posted Date March 15, 2021
Actual Study Start Date November 24, 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 6, 2020)
  • Baseline characteristics [ Time Frame: Through study completion, average 1 year ]
    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.
  • 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 in patients stratified by oncological 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 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.
  • Frequency of complications of COVID-19 infection in patients with prostate cancer stratified by anti-androgenic oncological treatment [ Time Frame: Through study completion, average 1 year ]
    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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 6, 2020)
  • COVID-19 mortality rate in patients with genitourinary cancer [ Time Frame: Through study completion, average 1 year ]
    To assess the mortality associated with COVID-19 infection in the population with genitourinary tumors. Percentage of patients alive / dead at discharge.
  • COVID-19 complication rate in patients with genitourinary cancer [ Time Frame: Through study completion, average 1 year ]
    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.
  • Asymptomatic rate [ Time Frame: Through study completion, average 1 year ]
    Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.
  • Frequency of delays/modifications on cancer treatment schedule [ Time Frame: Through study completion, average 1 year ]
    delays / modifications in cancer follow-up or treatment regimens. The average delay time and the number of modifications will be evaluated.
  • Progression free survival in patients with genitourinary tumors that suffered COVID-19 [ Time Frame: Through study completion, average 1 year ]
    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
  • Overall survival in patients with genitourinary tumors that suffered COVID-19 [ Time Frame: Through study completion, average 1 year ]
    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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Description of the Population With Genitourinary Tumors and COVID-19
Official Title Observational Retrospective-prospective Study in Patients With Genitourinary Tumors Presenting COVID-19 Infection (SOGUG-COVID-19)
Brief 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.

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:

  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.

Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
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.
Condition
  • Covid19
  • Genito Urinary Cancer
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 6, 2020)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Federico Nepote 934344412 investigacion@mfar.net
Contact: Verónica Roca 934344412 investigacion@mfar.net
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04578132
Other Study ID Numbers SOG-INM-2020-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Spanish Oncology Genito-Urinary Group
Study Sponsor Spanish Oncology Genito-Urinary Group
Collaborators Not Provided
Investigators
Study Chair: Miguel Ángel Climent, M.D., Ph.D. Instituto Valenciano de Oncología
Study Chair: Javier Puente, M.D., Ph.D. Hospital Clínico San Carlos de Madrid
Study Chair: Aránzazu González del Alba, M.D., Ph.D. Hospital Universitario Puerta de Hierro-Majadahonda
Study Chair: Sergio Vázquez Estevez, M.D., Ph.D. Hospital Universitario Lucus Augusti
Study Chair: Natalia Vidal, M.D., Ph.D. Hospital Clínico San Carlos de Madrid
PRS Account Spanish Oncology Genito-Urinary Group
Verification Date March 2021