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NCT Number: NCT06542926

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.

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Key information

Conditions

Liver Metastases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

liver resection

Procedure

Resection of non-colorectal liver metastases

Other names: hepatectomy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Study contacts

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

Matteo Donadon, MD, PhD

CONTACT

[email protected]

003903213733045

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Other

Registry information

Official study title

Electronic Dataset of NON-COlorectal Liver METastases Undergoing Liver Resection

Acronym: NONCOLMET

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Aug 7, 2024
Registry last updated
Aug 7, 2024

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.

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