NON-COlorectal Liver METastases Undergoing Liver Resection (NONCOLMET)

August 6, 2024 updated by: Matteo Donadon, Azienda Ospedaliero Universitaria Maggiore della Carita

Electronic Dataset of NON-COlorectal Liver METastases Undergoing Liver Resection

Liver metastases (LM) are common in various types of malignant diseases, either at the diagnosis of the primary tumour or at a later time point. While the resection of colorectal LM (CRLM) is a well-established procedure, with survival rates superior to chemotherapy alone, controversial data still exist on liver resection for non-colorectal LM (NCRLM) (2, 3). These patients comprise a diverse and heterogeneous group usually excluded from surgery due to advanced tumour stage or the presence of concomitant extrahepatic disease. To date, no randomized clinical trial on the surgical treatment of NCRLM has been conducted, and only few retrospective reports are available.The scope of this research project is to develop a large registry of patients undergoing liver surgery for non-colorectal liver metastases.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

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

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

All patients with a diagnosis, based on imaging methods and histologically confirmed, of NCRLM, consecutively referred to centres with expertise in hepatobiliary surgery will be evaluated for inclusion. For the diagnosis and staging of disease the participating centres will refer to the guidelines for NCRLM, together with the established clinical habits present in each centre

Description

Inclusion criteria:

  • Signature informed consent
  • Age ≥ 18 years
  • Histologically confirmed diagnosis of NCRLM (first diagnosis or relapse)
  • Liver resection performed.

Exclusion criteria

  • ASA IV
  • Severe psychiatric pathology
  • Unable to follow a clinical examination pattern during observation.
  • Patient submitted exclusively to interventional locoregional procedures other than liver resection.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From date of enrollment until the date of death from any cause assessed up to 36 months
Overall Survival defined as the time elapsed between the date of resective surgery and the date of death for any reason. Patients who are surviving at the end of observation will be considered "censored" at the date of the last available follow-up.
From date of enrollment until the date of death from any cause assessed up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free Survival
Time Frame: From date of enrollement until the date of first documented progression assessed up to 36 months
Disease-free Survival defined as the time from resective surgery to the date of first relapse or last available follow-up, whichever occurs first
From date of enrollement until the date of first documented progression assessed up to 36 months

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Investigators

  • Principal Investigator: Matteo Donadon, MD, PhD, AOU della Carità, Novara, Italy

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 (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NONCOLMET01

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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