Prospective Sample Collection for Cancer of Bladder

NCT03973671 | Recruiting

• 1 other identifier: S55725
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the Flemish Databank for Urothelial Cancer is to collect clinical and pathological data of patients treated for urothelial cancer (UC).

Conditions

Urinary Bladder Neoplasms

Keywords

Risk stratification; Recurrence; Progression; Non-muscle-invasive bladder cancer; Muscle-invasive bladder cancer

Outcome Measures

Primary Outcomes (1)

• Progression to MIBC

  Histopathologically proven muscle-invasive bladder cancer (at least T2 disease) in pathological evaluation of the TURBT specimen

  10 years

Secondary Outcomes (1)

• Recurrence of NMIBC

  5 years

Study Arms (1)

UC patients

Patients diagnosed with primary or recurrent non-muscle-invasive bladder (NMIBC) cancer. No experimental intervention will be administered. NMIBC patients will be diagnosed, treated and followed up according to guidelines-based institutional routines. The clinical (demographic, operative and follow-up) and pathological data of the patients will be collected in a complete anonymous way.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients treated at University Hospitals Leuven for urothelial cancer that fit the aforementioned inclusion and exclusion criteria.

You may qualify if:

• who are aged between 18-90,
• who are of male or female sex,
• who give their informed consent to collect their clinical and pathological data,
• who are planned to undergo TURBT for BC,
• who are planned to undergo (salvage) radical cystectomy with or without an extended pelvic lymph node dissection,
• who are planned to undergo tumor biopsy (from primary or metastatic tumor),
• who are planned to undergo radical nephroureterectomy ± partial cystectomy or segmental ureterectomy, with or without a lymph node dissection,
• who are planned to undergo endoscopic tumor biopsy or resection,
• from whom metastases will be surgically removed.

You may not qualify if:

• patients who do not give their informed consent to collect their clinical and pathological data,
• patients who withdraw their informed consent to use their clinical and pathological data,
• patients who refuse the planned treatment,
• women who are pregnant or have suspicion of pregnancy.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fresh-frozen urine, whole blood and bladder cancer tissue (from which DNA/RNA will be extracted in the future). These biosamples will be stored at -80°C at the BioBank UZ Leuven.

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Recurrence; Disease Progression; Non-Muscle Invasive 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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Steven Joniau, MD, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

• Frank Van Der Aa, MD, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Murat Akand, MD

CONTACT

+3216346687; murat.akand@uzleuven.be

Tim Muilwijk, MD

CONTACT

+3216346104; tim.muilwijk@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 4, 2019
• Study Start: May 29, 2020
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2032
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)