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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

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.


Condition or disease
Covid19 Genito Urinary Cancer

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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Ecologic or Community
Time Perspective: Other
Official Title: Observational Retrospective-prospective Study in Patients With Genitourinary Tumors Presenting COVID-19 Infection (SOGUG-COVID-19)
Actual Study Start Date : November 24, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.

  4. 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.

  5. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Asymptomatic rate [ Time Frame: Through study completion, average 1 year ]
    Describe the frequency of asymptomatic or minimally symptomatic COVID-19 infections.

  4. 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.

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04578132


Contacts
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Contact: Federico Nepote 934344412 investigacion@mfar.net
Contact: Verónica Roca 934344412 investigacion@mfar.net

Locations
Show Show 32 study locations
Sponsors and Collaborators
Spanish Oncology Genito-Urinary Group
Investigators
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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
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Responsible Party: Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov Identifier: NCT04578132    
Other Study ID Numbers: SOG-INM-2020-04
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Spanish Oncology Genito-Urinary Group:
Urothelial cancer
prostate cancer
Germ line cancer
Kidney cancer
COVID-19
Additional relevant MeSH terms:
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Urogenital Neoplasms
Neoplasms by Site
Neoplasms