Clinical trial NCT06863844: The Evaluation of Molecular Markers From PRedittivI DNA of Clinical Outcomes in Patients With UROthelial Tumor
Official title: Study for the Evaluation of Molecular Markers Extracted From PRedittivI DNA of Clinical Outcomes and Response to Systemic Therapy in Patients With UROthelial Tumor.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urothelial Neoplasm
Keywords: biomarker
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with urothelial cancer

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.

Eligibility criteria: 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.

Primary outcomes:
measure: evaluation of the prognostic and predictive role of response to systemic therapy of specific molecular markers extracted from tumor DNA.
timeFrame: 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:
measure: molecular profiles predictive of response/resistance to chemotherapy, immune-checkpoint inhibitors, target therapy
timeFrame: 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
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero Universitaria Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Francesco Massari, MD
role: PRINCIPAL_INVESTIGATOR
References: