The Evaluation of Molecular Markers From PRedittivI DNA of Clinical Outcomes in Patients With UROthelial Tumor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Urothelial Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Primary outcome measures
- evaluation of the prognostic and predictive role of response to systemic therapy of specific molecular markers extracted from tumor DNA. [Time frame: 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 outcome measures (1)
- molecular profiles predictive of response/resistance to chemotherapy, immune-checkpoint inhibitors, target therapy [Time frame: 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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero Universitaria Bologna — Bologna
Identifiers
NCT: NCT06863844 · PROCURO · RC-2022-2773372