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

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lymph Node Neoplasms Neoplasms by Site Sentinel Node

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Besancon

Besançon, 25030, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Colectomy for Non metastatic colon cancer

Exclusion criteria

Tumor T4
No medical insurance
Pregnant woman
Psychiatric disorders

Treatment and study plan

Immunochemistry and molecular biology on sentinel lymph node specimen

Procedure

Primary outcomes

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.

Secondary outcomes

Disease-free survival

Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: UNMASK

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Aug 10, 2016
Registry last updated: Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed