Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06863844

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Urothelial Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero Universitaria Bologna

Bologna, 40138, Italy

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

    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

Secondary outcomes

  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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Massari, MD

CONTACT

[email protected]

+390512142204

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study 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.

Acronym: PROCURO

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.