Liver Metastasis Colon CancerNCT04634526
Prospective Clinical Study of Intraoperative Assessment of Resection Margin of Colo-Rectal Cancer Liver Metastases
An observational study of Liver Metastasis Colon Cancer, run by Oncology Institute of Vojvodina at 1 site in Serbia.
Trial summary
This prospective single arm double-blind study approved by the Ethics Committee of the institution, will be conducted on at the Oncology Institute of Vojvodina in Sremska Kamenica, Serbia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Liver Metastasis Colon Cancer
- How many people
- 250 participants
- Where
- 1 siteSerbia
- Study dates
- 18 Apr 2018to 1 Jan 2026
- How long will I take part?
- 5 Years
- 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 85 years
- All sexes
- Adult, Older adult
Study population: All patients with liver resection for liver metastases or colo-rectal cancer
Who may be able to join
- Older than 18 years
- Preoperative diagnosis of liver metastases of colorectal adenocarcinoma
- Indication for surgical resection of liver metastases of colorectal adenocarcinoma
Who cannot join
- RM is not defined by surgeons and pathologists as positive or negative
- Surgical resections and application of ablative procedures at the same time
- Surgery for relapse of CRLM, if the first CRLM surgery is performed before this study start
- Resection was not done from any reason
Trial locations and contacts
1 site in 1 country.
Serbia1 site, 1 recruiting
- Recruiting
Oncology Institute of Vojvodina
Kamenitz, 21204
Mladjan Protic, mlprotic@gmail.com
About this study
This prospective single arm double-blind study approved by the Ethics Committee of the institution, will be conducted on at the Oncology Institute of Vojvodina in Sremska Kamenica, Serbia. Patients with colo-rectal cancer liver metastases (CRLM) is presented to the multi-disciplinary team (MDT).Screening and enrolment is conducted after established of indication for resection. The surgeons assesses resection margin (RM) for every resected liver specimen (RLS) intra-operatively by inspection and palpation. These data will be compared with pathological RM examination as a "gold standard". Resection margin of 1 mm or more will be rated as negative RM (RM-) otherwise RM is positive (RM+). Taking the result of the pathohistological examination as "gold standard" it is determined that RM is true positive when the pathologist and surgeon agreed that the RM is positive. False negative RM is when the surgeon assesses RM as negative and pathologist as positive. The sensitivity of the surgical assessment of RM+ is defined as the rate of RM+ which was correctly identified. True negative RM is determined when the pathologist and surgeon agreed that it is negative RM. False positive RM defined when the surgeon assessed RM as positive, but pathologist found that it was RM-. The specificity of the surgical assessment of RM is defined as the rate of RM- which is correctly identified. Total accuracy represents the rate of correctly recognized positive and negative RM, relative to the total number of samples. Agreement between surgeon and pathologists finding will be analyzed as well as difference between them. Disease recurrence and disease-free survival (DFS) will be analyzed by RM.
- Conditions
- Liver Metastasis Colon Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of R1 cases assessed by surgeon
Resection margin defined by surgeon could be negative (R0), positive without residual tumor (R1) and positive with residual tumor (R2)
Measured: at the operation
Secondary outcomes (2)
Recurrence rate
Percentage of patients with recurrence of disease
Measured: up to 5-years
Disease free survival
Time period from operation to the disease recurrence
Measured: up to 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start18 Apr 2018
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver Metastasis Colon CancerStudies 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
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Oncology Institute of Vojvodina
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mladjan Protic, Oncology Institute of Vojvodina
- Investigators
- Mladjan Protic, Principal investigator, Oncology Institute of Vojvodina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634526
- Sponsor's protocol ID
- No 4/18/1-972-9
- Status last verified
- Nov 2020
- First submitted
- 10 Nov 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Protic M, Krsmanovic O, Solajic N, Kukic B, Nikolic I, Bogdanovic B, Radovanovic Z, Kresoja M, Mannion C, Man YG, Stojadinovic A. Prospective Non-Randomized Study of Intraoperative Assessment of Surgical Resection Margin of Colo-Rectal Liver Metastases. J Cancer. 2021 Apr 30;12(12):3701-3714. doi: 10.7150/jca.58580. eCollection 2021.
PubMed 33995645
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of Intraoperative Assessment of Resection Margin of Colo-Rectal Cancer Liver Metastases
- ClinicalTrials.gov ID
- NCT04634526
- Acronym / sponsor ID
- No 4/18/1-972-9
- Conditions
- Liver Metastasis Colon Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Oncology Institute of VojvodinaOther government
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 18 Nov 2020 (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.
This prospective single arm double-blind study approved by the Ethics Committee of the institution, will be conducted on at the Oncology Institute of Vojvodina in Sremska Kamenica, Serbia. Patients with colo-rectal cancer liver metastases (CRLM) is presented to the multi-disciplinary team (MDT).Screening and enrolment is conducted after established of indication for resection. The surgeons assesses resection margin (RM) for every resected liver specimen (RLS) intra-operatively by inspection and palpation. These data will be compared with pathological RM examination as a "gold standard". Resection margin of 1 mm or more will be rated as negative RM (RM-) otherwise RM is positive (RM+). Taking the result of the pathohistological examination as "gold standard" it is determined that RM is true positive when the pathologist and surgeon agreed that the RM is positive. False negative RM is when the surgeon assesses RM as negative and pathologist as positive. The sensitivity of the surgical assessment of RM+ is defined as the rate of RM+ which was correctly identified. True negative RM is determined when the pathologist and surgeon agreed that it is negative RM. False positive RM defined when the surgeon assessed RM as positive, but pathologist found that it was RM-. The specificity of the surgical assessment of RM is defined as the rate of RM- which is correctly identified. Total accuracy represents the rate of correctly recognized positive and negative RM, relative to the total number of samples. Agreement between surgeon and pathologists finding will be analyzed as well as difference between them. Disease recurrence and disease-free survival (DFS) will be analyzed by RM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with liver resection for liver metastases or colo-rectal cancer
Key inclusion criteria (3 listed)
- Older than 18 years
- Preoperative diagnosis of liver metastases of colorectal adenocarcinoma
- Indication for surgical resection of liver metastases of colorectal adenocarcinoma
Key exclusion criteria (4 listed)
- RM is not defined by surgeons and pathologists as positive or negative
- Surgical resections and application of ablative procedures at the same time
- Surgery for relapse of CRLM, if the first CRLM surgery is performed before this study start
- Resection was not done from any reason
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
Rate of R1 cases assessed by surgeon
Time frame: at the operation
Resection margin defined by surgeon could be negative (R0), positive without residual tumor (R1) and positive with residual tumor (R2)
2 secondary outcomes
Recurrence rate
Time frame: up to 5-years
Disease free survival
Time frame: up to 5-years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Derived from this study: PubMed 33995645Protic M, Krsmanovic O, Solajic N, Kukic B, Nikolic I, Bogdanovic B, Radovanovic Z, Kresoja M, Mannion C, Man YG, Stojadinovic A. Prospective Non-Randomized Study of Intraoperative Assessment of Surgical Resection Margin of Colo-Rectal Liver Metastases. J Cancer. 2021 Apr 30;12(12):3701-3714. doi: 10.7150/jca.58580. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
Mladjan Protic principal investigator
Oncology Institute of Vojvodina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Metastasis Colon Cancer, run by Oncology Institute of Vojvodina at 1 site in Serbia.
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 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: status not confirmed, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mladjan Protic, MD,PhD (+381641253308, mlprotic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of R1 cases assessed by surgeon (time frame: at the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04634526, which also lists 1 linked publication.
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 18 Nov 2020.