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NCT04806178CompletedPhase 3

Immunological Response of Bladder Cancer Patients Under BCG

Systemic Immunological Response of Bladder Cancer Patients Under Bacillus Calmette Guérin Treatment

Source: ClinicalTrials.gov · Last updated 9 Dec 2024

Brief summary (registry, in English)

Bladder cancer (BC) is one of the most common cancers worldwide and the most successful example of vaccine in cancer treatment, representing an efficient model for studying the importance of systemic and local immune mechanisms. Despite being the standard of treatment for the last 40 years, the exact mode of action of immunotherapy with the bacillus Calmette-Guérin (BCG) is still poorly defined. In a mechanistic study, the investigators intend to prospectively investigate immunological signatures, including immune-checkpoints, pre and post-treatment in patients with BC, and correlate the cytokines of the immune by-product and BCG administration pathway to understand the independent contributions of BCG priming (prior exposure to BCG) and crosstalk immunotherapy between tumor profiles and immune response of the patient. The proposed research strategy is justified by the need to identify subsets of patients who better respond to an intervention, or to predict why new immunotherapies and drugs may be successful or failed in clinical trials.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
30 (actual)
First submitted
12 Mar 2021
Start date
3 Sept 2021
Primary completion date
24 May 2024
Lead sponsor
University of Campinas, Brazil
NCT number
NCT04806178

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 30
  • From 3 Sept 2021 to the primary completion date, 24 May 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous BCG treatment;

Other

  • Muscle invasive tumor.

Who the study is looking for

  • NMIBC with the indication for intravesical BCG treatment;

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pontifical Catholic University of Campinas Hospital
Coordinator of this site? Confirm its status
CampinasBrazilUnknown status
Hospital das Clinicas - UNICAMP
Coordinator of this site? Confirm its status
CampinasBrazilUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.