Ex-vivo Sentinel Lymph Node in Stage I-II Colon Cancer: Kappa Analysis With Immunochemistry and Molecular Biology (UNMASK)
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|ClinicalTrials.gov Identifier: NCT02861430|
Recruitment Status : Unknown
Verified August 2016 by Zaher Lakkis, Centre Hospitalier Universitaire de Besancon.
Recruitment status was: Recruiting
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
|Condition or disease||Intervention/treatment|
|Colon Cancer Lymph Node Sentinel Node||Procedure: Immunochemistry and molecular biology on sentinel lymph node specimen|
|Study Type :||Observational|
|Estimated Enrollment :||388 participants|
|Official Title:||Ex-vivo Sentinel Lymph Node in Stage I-II Colon Cancer: Kappa Analysis With Immunochemistry and Molecular Biology|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||March 2020|
Procedure: Immunochemistry and molecular biology on sentinel lymph node specimen
- 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.
- Disease-free survival [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861430
|Contact: Zaher Lakkis, MD||+00 33 firstname.lastname@example.org|
|Besancon, France, 25030|