The Evaluation of Molecular Markers From PRedittivI DNA of Clinical Outcomes in Patients With UROthelial Tumor

Recruiting

• Conditions: Urothelial Neoplasm

• Registration Number: NCT06863844
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

The genetic characterization of urothelial tumor disease has brought to light important information about the biology of the disease. The evaluation of molecular DNA markers on tumor tissue could be an approach able to provide important information on the possible aggressiveness of the disease and the sensitivity/resistance profile to drugs commonly adopted in the advanced stage. The main objective of this study is to identify specific molecular profiles from DNA capable of predicting the clinical course of the disease and the possible sensitivity/resistance of the disease to systemic treatments

Detailed Description

retrospective and prospective evaluation concerning the identification of molecular profiles on DNA obtained from tumor tissue previously obtained from patients with urothelial cancer and analyzed with massive sequencing method (Next Generation Sequencing).

Analysis of data obtained from anamnestic data, clinical data, blood chemistry tests, histopathological examinations and instrumental imaging.

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2024-11
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-03-03
• Last Update Submitted: 2025-03-03
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evaluation of the prognostic and predictive role of response to systemic therapy of specific molecular markers extracted from tumor DNA.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months	The study involves the analysis by massive sequencing (Next Generation Sequencing) of molecular profiles of tumor DNA extracted from tumor tissue obtained during surgery (on primary and/or metastases) or diagnostic biopsy performed as part of the normal clinical care pathway. These data will be integrated with information relating to anamnestic data and clinical, laboratory and instrumental parameters of patients with urothelial neoplasia

Secondary Outcome Measures

Name	Time	Method
molecular profiles predictive of response/resistance to chemotherapy, immune-checkpoint inhibitors, target therapy	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months	Search for molecular profiles predictive of response/resistance to chemotherapy, immune-checkpoint inhibitors, target therapy

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero Universitaria Bologna; 🇮🇹 Bologna, Italy