Translational Cancer Observational Protocol

December 5, 2023 updated by: Francesco Montorsi, IRCCS San Raffaele

2014 Transizionali - Observational Study on the Occurrence of Relapses and on the Quality of Life in Patients Who Underwent Nephroureterectomy Surgery

Observational study on relapse occurrence and on the quality of life in patients who underwent nephroureterectomy surgery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Monocentric prospective and retrospective observational study on the quality of life and on the pathological status in patients who underwent nephroureterectomy surgery. Oncological, psychological, sexual and quality of life-related data will be collected within a specifically created database that will allow us an easy and secure data extraction for the statistical analysis required by the clinical trial in terms of oncological relapse, clinical progression and improve the assistance and therapeutic strategy for each patient. Retrospective data for patients who underwent surgery between 1987 and today will be available in the form of clinical report stored in the hospital archives.

Study Type

Observational

Enrollment (Estimated)

1250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with upper tract urothelial cancer who underwent nephroureterectomy surgery.

Description

Inclusion Criteria:

  • 18 years or older
  • Upper tract urothelial cancer diagnosis
  • Indication to cancer removal through nephroureterectomy surgery
  • Ability to read and sign the informed consent

Exclusion Criteria:

  • Age < 18 years
  • Absence of upper tract urothelial cancer
  • Inability to read and sign the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental
Patients with upper urinary tract urothelial cancer who underwent nephroureterectomy surgery
Procedure: Nephroureterectomy
Removal of cancer mass by urether and kidney complete resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical progression data collection
Time Frame: 50 years
Collection intended for the purpose of implementing diagnostic and therepautic strategies for the management of the disease in both the patient enrolled in the study and for future cases. Data will be collected in a dedicated internal database by means of medical records obtained during the patients' stay in the hospital and during follow up visits. The data collected includes anamnesis, data regarding surgery, laboratory exam and imaging exams.
50 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Francesco Montorsi, MD, IRCCS Ospedale San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2014

Primary Completion (Estimated)

July 17, 2064

Study Completion (Estimated)

July 17, 2064

Study Registration Dates

First Submitted

November 23, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Estimated)

December 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014 - Transizionali

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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