A Study to Characterize High-Risk Non-Muscle-Invasive Bladder Cancer Participants in Portugal

NCT07784387 | Recruiting

• 1 other identifier: 17000139BLC4007
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand how the participants with high-risk non-muscle invasive bladder cancer are diagnosed, treated, and cared for in regular clinical practice in Portugal. HR-NMIBC is an early-stage bladder cancer that is limited to the inner lining of bladder but has a considerable high chance of cancer coming back or worsening.

Conditions

Urinary Bladder Neoplasms

Outcome Measures

Primary Outcomes (5)

• Treatment Patterns: Type of Therapeutic Approach

  Number of participants receiving different types of therapeutic approach including bacillus calmette-guerin (BCG) therapy, chemotherapy, radiotherapy, immunotherapy, or targeted therapy will be reported.

  Up to 5 years

• Treatment Patterns: Type of Surgery

  Number of participants undergoing different types of surgery, including transurethral resection of the bladder tumor (TURBT), repeat TURBT or cystectomy will be reported.

  Up to 5 years

• Treatment Patterns by Subpopulation: Tumor Stage

  Number of participants by tumor stage will be reported.

  Up to 5 years

• Treatment Patterns by Subpopulation: Histology

  Number of participants by histology will be reported.

  Up to 5 years

• Treatment Patterns by Subpopulation: Line of Therapy

  Number of participants by line of therapy will be reported,

  Up to 5 years

Secondary Outcomes (12)

• Total Number of BCG Doses Administered

  Up to 5 years

• Percentage of Participants With BCG Non-Responsive Disease

  Up to 5 years

• Reasons for BCG Interruption

  Up to 5 years

• Therapy Choice at Recurrence

  Up to 5 years

• Recurrence-Free Survival (RFS)

  Up to 5 years

Study Arms (1)

HR-NMIBC Participants: Portuguese Routine Practice

Participants diagnosed with high-risk non-muscle-Invasive bladder cancer (HR-NMIBC) in Portugal between January 1, 2016 and December 31, 2020, with tumor stage N0/x and M0/x and one of the following: Tis (primary CIS), TaG3/HG, or T1 will be enrolled. Demographic and clinical information will be gathered from both electronic and paper records for each participant. Only data available within routine clinical practice from the diagnosis until, at least, 5 years after diagnosis will be collected in this study. No drug will be administered as a part of this study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes the participants from Portuguese hospitals that treat and manage High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) in routine clinical practice.

You may qualify if:

• Bladder cancer diagnosis between January 1, 2016 and December 31, 2020
• Tumor stage N0/x and M0/x plus any of the following: Tis (primary CIS); TaG3/HG (high-grade non-invasive papillary carcinoma); or T1 (tumor invading subepithelial connective tissue)
• Minimal follow-up time of 5 years unless there is premature death event

You may not qualify if:

• Tumor stage at diagnosis classified as TaG1-2, T2-T4, N1-3, or M1
• History of radical cystectomy performed either prior to the HR-NMIBC index diagnosis or for an indication unrelated to the index HR-NMIBC
• Participation in any interventional clinical trial during the observation period

Sponsors & Collaborators

• Janssen-Cilag Farmaceutica Ltda.: lead

Study Sites (1)

Ipo Lisboa

Lisbon, 1099-023, Portugal

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Janssen-Cilag Farmaceutica Ltda. Clinical Trial

  Janssen-Cilag Farmaceutica Ltda.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 25, 2026
• Study Start: August 25, 2026
• Primary Completion (Estimated): February 15, 2028
• Study Completion (Estimated): February 25, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

PT (1)