Colorectal Cancer Stage IVNCT05164419
Impact de la Marge de résection Sur la Survie à Long Terme et le Taux de récidive Des Patients Atteints de Cancers Colorectaux opérés au CHUS Entre 2006 et 2016 Pour Des métastases hépatiques
An observational study of Colorectal Cancer Stage IV, run by Université de Sherbrooke.
Trial summary
We retrospectively looks at the impact of the margin status and its size in mm on the recurrence rate in colo-rectal liver metastasis surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colorectal Cancer Stage IV
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with colorectal liver metastases undergoing liver resection at our institution during the defined time-frame.
Who may be able to join
- Primary colorectal cancer with liver metastasis
- Undergone liver surgery at our center between 2011 and 2015
- Pathological reports with margin status available (or specimen still available for measurement)
Who cannot join
- Repeat liver resection No tissu or incomplete pathological information
About this study
We retrospectively looks at the impact of the margin status and its size in mm on the recurrence rate in colo-rectal liver metastasis surgery.
Read the detailed description
Main objective : evaluation the margin status (<1mm, 1-4mm, 5-9mm, >10mm) on the survival and recurrence in colo-rectal liver metastases surgery.
Secondary objectives include :
Evaluate potentiel effects of neo-adjuvant chemotherapy, portal embolisation, and evaluate potentiel bias such as size and number of liver metastases, TNM status of original tumor, timing between primary and metastasis, and extra-hepatic disease.
Methods :
A retrospective cohort study is built where all patients undergoing liver surgery for colorectal liver metastases between 2011 and 2015 are analysed. Subjects are separated in groups according to their margin status. The local and distal recurrence rates are measured and well as survival. Data is obtained through our hospital data management system. Inclusion criterias include age over 18, primary colorectal cancer metastatic to the liver, having undergone surgery between 2011 and 2015, available pathology reports with required data, available radiologic follow-up. Exclusion criterias include repeat liver resection, documented grossly positive margins (R2 resection), and unavailable pathologic information and follow-up. Using survival as primary outcome (Kaplan Meier) and considering 25% potential loss to follow-up, we calculated a sample size. Since this a retrospective study, no patient is directly contacted. Data will is handled by the surgery resident responsible for the project as well as by research assistants. Statistical analysis are performed accordingly.
- Conditions
- Colorectal Cancer Stage IV
- Keywords
- liver surgery, Colorectal liver metastasis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Wide margin | Patients who underwent surgery with a final pathologic margin of more than 5mm. | |
| Close margin | Patients who underwent surgery with a final pathologic margin of less than 5mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Patient is dead or aline
Measured: 2 years
Secondary outcomes (2)
Local recurrence
Advent of recurrence in the liver parenchyma, measured by any time of medical imaging
Measured: 2 years
Distant recurrence
Advent of recurrence anywhere other than liver, measured by any time of medical imaging
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start1 Jan 2006
- Primary completion31 Dec 2016
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164419
- Sponsor's protocol ID
- 2017-1611
- Status last verified
- May 2023
- First submitted
- 7 Dec 2021
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact de la Marge de résection Sur la Survie à Long Terme et le Taux de récidive Des Patients Atteints de Cancers Colorectaux opérés au CHUS Entre 2006 et 2016 Pour Des métastases hépatiques
- ClinicalTrials.gov ID
- NCT05164419
- Acronym / sponsor ID
- 2017-1611
- Conditions
- Colorectal Cancer Stage IV
- Keywords
- liver surgery, Colorectal liver metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Dec 2021 (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.
We retrospectively looks at the impact of the margin status and its size in mm on the recurrence rate in colo-rectal liver metastasis surgery.
Detailed description
Main objective : evaluation the margin status (<1mm, 1-4mm, 5-9mm, >10mm) on the survival and recurrence in colo-rectal liver metastases surgery.
Secondary objectives include :
Evaluate potentiel effects of neo-adjuvant chemotherapy, portal embolisation, and evaluate potentiel bias such as size and number of liver metastases, TNM status of original tumor, timing between primary and metastasis, and extra-hepatic disease.
Methods :
A retrospective cohort study is built where all patients undergoing liver surgery for colorectal liver metastases between 2011 and 2015 are analysed. Subjects are separated in groups according to their margin status. The local and distal recurrence rates are measured and well as survival. Data is obtained through our hospital data management system. Inclusion criterias include age over 18, primary colorectal cancer metastatic to the liver, having undergone surgery between 2011 and 2015, available pathology reports with required data, available radiologic follow-up. Exclusion criterias include repeat liver resection, documented grossly positive margins (R2 resection), and unavailable pathologic information and follow-up. Using survival as primary outcome (Kaplan Meier) and considering 25% potential loss to follow-up, we calculated a sample size. Since this a retrospective study, no patient is directly contacted. Data will is handled by the surgery resident responsible for the project as well as by research assistants. Statistical analysis are performed accordingly.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wide margin | – | –Patients who underwent surgery with a final pathologic margin of more than 5mm. |
| Close margin | – | –Patients who underwent surgery with a final pathologic margin of less than 5mm |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with colorectal liver metastases undergoing liver resection at our institution during the defined time-frame.
Key inclusion criteria (3 listed)
- Primary colorectal cancer with liver metastasis
- Undergone liver surgery at our center between 2011 and 2015
- Pathological reports with margin status available (or specimen still available for measurement)
Key exclusion criteria (1 listed)
- Repeat liver resection No tissu or incomplete pathological information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 2 years
Patient is dead or aline
2 secondary outcomes
Local recurrence
Time frame: 2 years
Distant recurrence
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Stage IV, run by Université de Sherbrooke.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 31 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years). 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 31 May 2023.