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NCT02861430 Clinical Trial

Ex-vivo Sentinel Lymph Node in Stage I-II Colon Cancer: Kappa Analysis With Immunochemistry and Molecular Biology

Colon Cancer Clinical Trial

— UNMASK  

Official title:
Ex-vivo Sentinel Lymph Node in Stage I-II Colon Cancer: Kappa Analysis With Immunochemistry and Molecular Biology

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02861430
Other study ID # Besancon Unmask
Secondary ID
Status Recruiting
Phase N/A
First received August 2, 2016
Last updated August 5, 2016
Start date April 2014
Est. completion date March 2020

Study information
Verified date August 2016
Source Centre Hospitalier Universitaire de Besancon
Contact Zaher Lakkis, MD
Phone +00 33 637968298
Email zlakkis@chu-besancon.fr
Is FDA regulated No
Health authority France: Committee for the Protection of Personnes
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 388
Est. completion date March 2020
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Colectomy for Non metastatic colon cancer

Exclusion Criteria:

- Tumor T4

- No medical insurance

- Pregnant woman

- Psychiatric disorders

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Immunochemistry and molecular biology on sentinel lymph node specimen

Locations
Country Name City State
France CHRU Besancon Besancon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.		 1 month No
Secondary Disease-free survival 3 years No
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