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

NCT ID: NCT06863844

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Urothelial Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francesco Massari, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero Universitaria Bologna

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesco Massari, MD

Role: CONTACT

+390512142204

Other Identifiers

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RC-2022-2773372

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PROCURO

Identifier Type: -

Identifier Source: org_study_id

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