Colon CancerUNMASKNCT02861430
Ex-vivo Sentinel Lymph Node in Stage I-II Colon Cancer: Kappa Analysis With Immunochemistry and Molecular Biology
An observational study of Colon Cancer and Lymph Node, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Unmask Trial aims to evaluate the Kappa concordance between immunochemistry and molecular biology to detecting cancer cells in sentinel lymph node in patients undergoing colectomy for non metastatic colon cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Lymph Node, Sentinel Node
- What is being tested?
- Immunochemistry and molecular biology on sentinel lymph node specimen
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Apr 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Colon cancer
Who may be able to join
- Colectomy for Non metastatic colon cancer
Who cannot join
- Tumor T4
- No medical insurance
- Pregnant woman
- Psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Unmask Trial aims to evaluate the Kappa concordance between immunochemistry and molecular biology to detecting cancer cells in sentinel lymph node in patients undergoing colectomy for non metastatic colon cancer.
- Conditions
- Colon Cancer, Lymph Node, Sentinel Node
- Being tested
- Immunochemistry and molecular biology on sentinel lymph node specimen
- Keywords
- colon cancer, sentinel node
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunochemistry and molecular biology on sentinel lymph node specimenProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Procedure: Immunochemistry and molecular biology on sentinel lymph node specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between immunochemistry and molecular biology
The primary outcome is the rate of concordance between the number of positive sentinel lymph nodes detected by immunochemistry using an anti-cytokeratin antibody (KL1) and molecular biology targeting CK20 on tumoral RNA after RT-PCR.
The rate of positivity of the sentinel lymph nodes will be then compared to the standard technique using HES coloration used in routine pathological examination.
Only the result using the routine examination will be used to decide whether the patient should benefit from an adjuvant chemotherapy.
Measured: 1 month
Secondary outcomes (1)
Disease-free survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startApr 2014
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaher Lakkis, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861430
- Sponsor's protocol ID
- API-2012-30
- Acronym
- UNMASK
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex-vivo Sentinel Lymph Node in Stage I-II Colon Cancer: Kappa Analysis With Immunochemistry and Molecular Biology
- ClinicalTrials.gov ID
- NCT02861430
- Acronym / sponsor ID
- UNMASK / API-2012-30
- Conditions
- Colon Cancer, Lymph Node, Sentinel Node
- Keywords
- colon cancer, sentinel node
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 10 Aug 2016 (estimated)
- 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.
Unmask Trial aims to evaluate the Kappa concordance between immunochemistry and molecular biology to detecting cancer cells in sentinel lymph node in patients undergoing colectomy for non metastatic colon cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Immunochemistry and molecular biology on sentinel lymph node specimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colon cancer
Key inclusion criteria (1 listed)
- Colectomy for Non metastatic colon cancer
Key exclusion criteria (4 listed)
- Tumor T4
- No medical insurance
- Pregnant woman
- Psychiatric disorders
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 |
|---|---|---|
| Immunochemistry and molecular biology on sentinel lymph node specimen | Procedure or surgery | Patients |
Primary outcome
Concordance between immunochemistry and molecular biology
Time frame: 1 month
The primary outcome is the rate of concordance between the number of positive sentinel lymph nodes detected by immunochemistry using an anti-cytokeratin antibody (KL1) and molecular biology targeting CK20 on tumoral RNA after RT-PCR. The rate of positivity of the sentinel lymph nodes will be then compared to the standard technique using HES coloration used in routine pathological examination. Only the result using the routine examination will be used to decide whether the patient should benefit from an adjuvant chemotherapy.
1 secondary outcome
Disease-free survival
Time frame: 3 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 11 Feb 2025.
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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.
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 Colon Cancer and Lymph Node, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 11 Feb 2025. 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 France. 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?
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?
Concordance between immunochemistry and molecular biology (time frame: 1 month). 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 11 Feb 2025.