Liver MetastasesNONCOLMETNCT06542926
NON-COlorectal Liver METastases Undergoing Liver Resection
An observational study of Liver Metastases, run by Azienda Ospedaliero Universitaria Maggiore della Carita.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases
- What is being tested?
- liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Jun 2029
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Signature informed consent
- Age ≥ 18 years
- Histologically confirmed diagnosis of NCRLM (first diagnosis or relapse)
- Liver resection performed.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Liver Metastases
- Being tested
- liver resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver resectionProcedure or surgery
Also called hepatectomy
Resection of non-colorectal liver metastases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From date of enrollement until the date of first documented progression assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Donadon, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Matteo Donadon, MD, PhD, Principal investigator, AOU della Carità, Novara, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542926
- Sponsor's protocol ID
- NONCOLMET01
- Acronym
- NONCOLMET
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Dataset of NON-COlorectal Liver METastases Undergoing Liver Resection
- ClinicalTrials.gov ID
- NCT06542926
- Acronym / sponsor ID
- NONCOLMET / NONCOLMET01
- Conditions
- Liver Metastases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Signature informed consent
- Age ≥ 18 years
- Histologically confirmed diagnosis of NCRLM (first diagnosis or relapse)
- Liver resection performed.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liver resectionAlso: hepatectomyResection of non-colorectal liver metastases | Procedure or surgery | – |
Primary outcome
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.
1 secondary outcome
Disease-free Survival
Time frame: From date of enrollement until the date of first documented progression assessed up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matteo Donadon, MD, PhD principal investigator
AOU della Carità, Novara, Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Metastases, run by Azienda Ospedaliero Universitaria Maggiore della Carita.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo Donadon, MD, PhD (003903213733045, matteo.donadon@uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From date of enrollment until the date of death from any cause assessed up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.