Kidney Cancer Observational Protocol

November 23, 2023 updated by: Francesco Montorsi, IRCCS San Raffaele

2007 - Rene: Observational Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent Radical Nefrectomy/Tumorectomy Surgery

The aim of this observational study is to gather pre and post surgery clinical data belonging to patients who underwent radical or partial nephrectomy and to evaluate the impact of the surgery on the quality of life of the patients, as well as possible relapses within a 10 year period.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A databasa was created with the intention of collecting data related to patients who underwent radical or partial nefrectomy surgery in an electronic case report form.

Each patient will be followed for 10 years approximately starting from the date of surgery for a total of 2 yearly visits for the first 5 years which could then be diluted in 1 visit per year for the remaining 5 years. At each visit control exams forseen by the standard care for post surgery patients will be evalued and tha data will then be transferred into the database. Yearly, a follow up questionnaire will be sent to the patients' home in order to obtain the information relative to possible relapses. The data collected will be handled following the most strict GCPs and privacy norms. The main objectives of the study are the collection and interpretation of the scientific data with the scope of: obtaining health benefits for the patients involved and for future patients with the same type of cancer, improving the scientific knowledge on the pathology and implementing new strategies for diagnosis and therapy and evaluating the epidemiologic changes of renal neoplasia.

Study Type

Observational

Enrollment (Estimated)

2500

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 kidney cancer who underwent radical or partial nephrectomy

Description

Inclusion Criteria:

  • 18 years or older
  • Kidney cancer diagnosis
  • Indication to cancer removal through surgery
  • Ability to read and sign the informed consent

Exclusion Criteria:

  • Age < 18 years
  • Absence of kidney 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 kidney cancer who underwent radical or partial kidney removal surgery
Procedure: Radical or partial nephrectomy
Removal of neoplastic mass either by full kidney excision or by targeted cancer removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical parameter collection
Time Frame: 10 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.
10 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)

January 27, 2010

Primary Completion (Estimated)

February 4, 2028

Study Completion (Estimated)

February 4, 2028

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

November 23, 2023

First Posted (Actual)

November 27, 2023

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007 - Rene

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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