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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial population

Patients diagnosed with urothelial cancer

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

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 outcomes

1

molecular profiles predictive of response/resistance to chemotherapy, immune-checkpoint inhibitors, target therapy

Search for 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

Other outcomes

Sponsors and contacts

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