Prospective Collection of Samples for Urothelial Cancer of Bladder

NCT04167332 | Not Yet Recruiting DMC

• 1 other identifier: S59371
• Study Type: observational
• Target: 630
• Locations: 0 countries
• Sites: N/A

Brief Summary

ProCSUCaB (Prospective Collection of Samples for Urothelial Cancer of Bladder) is a monocentric, non-interventional, prospective registry that will recruit newly diagnosed intermediate- and high-risk NMIBC patients in a tertiary center in Flanders.

Conditions

Bladder Cancer

Keywords

Non-muscle-invasive bladder cancer; Progression; Recurrence; Registry; Prospective; Biomarker; Multi-omics

Outcome Measures

Primary Outcomes (3)

• Comprehensive multi-layered molecular characterization

  Comprehensive multi-layered molecular characterization of intermediate- and high-risk NMIBC patients at the genomics, epigenomics, transcriptomics, proteomics, lipidomics, metabolomics, and immunohistopathology levels for disease recurrence and progression

  In two years after completion of recruitment of planned number of patients

• Multi-biomarker panel for disease recurrence and progression

  Identification of a multi-biomarker panel that integrates multidimensional and longitudinal data with harnessing the power of various -omics, systems biology approach, network analysis and predictive modeling for a better stratification of intermediate- and high-risk NMIBC patients into their risk of recurrence and progression

  In two years after completion of recruitment of planned number of patients

• Multi-biomarker panel for response to BCG treatment

  Identification of a multi-biomarker panel for molecular characterization of a patient subgroup who receive BCG treatment, identification of the pathways relevant to BCG treatment response, and stratification of those patients according to their predicted BCG response

  In two years after completion of recruitment of planned number of patients

Study Arms (1)

NMIBC

Patients diagnosed with primary 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, and biosamples (blood, urine, bladder cancer tissue) of the patients will be collected in a completely anonymous way.

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

Patients of both sex and aged ≥18 years, with a signal of clinical diagnosis of bladder cancer (symptoms and/or imaging), who are willing to participate in this registry and who give their informed consent to collect their clinical data and biological materials prior to surgery.

You may qualify if:

• A signal of clinical diagnosis of bladder cancer (symptoms and/or imaging)
• Giving informed consent to collect clinical data and biological materials prior to surgery
• An approved pathological diagnosis of transitional cell carcinoma (TCC), with allowance of any variant histopathological subtype
• An approved pathological diagnosis of non-muscle-invasive bladder cancer (NMIBC), with stages of carcinoma in situ (CIS), Ta (mucosa-confined) and T1 (submucosa infiltrating)

You may not qualify if:

• Aged less than 18 years
• Not giving or withdrawing informed consent
• Tumor histopathological type other than TCC, such as adenocarcinoma, squamous cell carcinoma

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator
• HistoGeneX: collaborator
• MDx Health: collaborator
• Hospital Clinic of Barcelona: collaborator
• Mosaiques Diagnostics and Therapeutics AG: collaborator
• Biomedical Research Foundation, Academy of Athens: collaborator

Related Publications (2)

• Akand M, Veys R, Ost D, Vander Eeckt K, Baekelandt F, Van Reusel R, Mattelaer P, Baekelandt L, Van Cleynenbreugel B, Joniau S, Van der Aa F. Cohort Profile: VZNKUL-NMIBC Quality Indicators Program: A Flemish Prospective Cohort to Evaluate the Quality Indicators in the Treatment of Non-Muscle-Invasive Bladder Cancer. Cancers (Basel). 2024 Oct 29;16(21):3653. doi: 10.3390/cancers16213653.

  PMID: 39518090 DERIVED

• Akand M, Muilwijk T, Van Cleynenbreugel B, Gevaert T, Joniau S, Van der Aa F. Prototol for the Prospective Sample Collection for Cancer of Bladder (ProCaB) Trial by the Cancer of the Bladder Leuven (CaBLe) Consortium. Eur Urol Open Sci. 2024 Oct 15;70:21-27. doi: 10.1016/j.euros.2024.09.006. eCollection 2024 Dec.

  PMID: 39483518 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, and bladder cancer tissue.

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Disease Progression; Recurrence

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; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven Joniau, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

• Frank Van Der Aa, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Murat Akand, MD, FEBU

CONTACT

+32 16 34 69 30; murat.akand@uzleuven.be

Tim Muilwijk, MD

CONTACT

+32 16 34 69 30; tim.muilwijk@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 18, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After completion of data and biosample collection.
• Access Criteria: Upon request to the Steering Committee, and after request evaluated by the Steering Committee.