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

NCT06863844 | Recruiting

• 2 other identifiers: PROCURORC-2022-2773372
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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

Conditions

Urothelial Neoplasm

Keywords

biomarker

Outcome Measures

Primary Outcomes (1)

• evaluation of the prognostic and predictive role of response to systemic therapy of specific molecular markers extracted from tumor DNA.

  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

  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

Secondary Outcomes (1)

• 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

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 diagnosed with urothelial cancer

You may qualify if:

• \- Patients diagnosed with locally advanced operated or metastatic urothelial cancer in follow-up or treatment

You may not qualify if:

• \- Deceased patients who have not already performed the NGS analysis from clinical practice.
• For the prospective part:
• Patients
• aged \> 18 years
• suffering from locally advanced or metastatic urothelial neoplasia
• with the availability of tumor tissue obtained during surgery on a primary tumor or metastasis or during a diagnostic biopsy.
• Patients included in the study will also have to consciously express their willingness to participate in the study after signing the written informed consent.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero Universitaria Bologna

Bologna, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue

Study Officials

• Francesco Massari, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Massari, MD

CONTACT

+390512142204; francesco.massari@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: March 7, 2025
• Study Start: March 1, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: March 7, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)