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

Last updated: March 3, 2025
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urothelial Carcinoma

Treatment

N/A

Clinical Study ID

NCT06863844
PROCURO
RC-2022-2773372
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria For the retrospective part:

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

Exclusion Criteria For the retrospective part:

  • 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.

Study Design

Total Participants: 210
Study Start date:
March 01, 2023
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • IRCCS Azienda Ospedaliero Universitaria Bologna

    Bologna, 40138
    Italy

    Active - Recruiting

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