CClinicalTrials.gg
Not yet recruitingNCT06542926NONCOLMETUpdated Aug 7, 2024

NON-COlorectal Liver METastases Undergoing Liver Resection

An observational study in Liver Metastases, sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
300
Ages
18 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Liver Metastases
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In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 300 is above the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita is the lead sponsor of 54 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
300 participants (estimated)
Target follow-up
36 Months
Patient registry
Yes

Interventions

  • Procedureliver resection

    Resection of non-colorectal liver metastases

    Also known as: hepatectomy

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What researchers measure

Primary outcomes

  1. Overall Survival

    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.

    Time frame: From date of enrollment until the date of death from any cause assessed up to 36 months

Secondary outcomes

  1. Disease-free Survival

    Disease-free Survival defined as the time from resective surgery to the date of first relapse or last available follow-up, whichever occurs first

    Time frame: From date of enrollement until the date of first documented progression assessed up to 36 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06542926
Lead sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
Responsible party
Matteo Donadon (Professor of Surgery, Azienda Ospedaliero Universitaria Maggiore della Carita) — Principal investigator
First posted
Aug 7, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Aug 7, 2024

Study contacts

Matteo Donadon, MD, PhD
Contact
matteo.donadon@uniupo.it
003903213733045
Matteo Donadon, MD, PhD
principal investigator · AOU della Carità, Novara, Italy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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