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

Completed

• Conditions: Sentinel Node; Colon Cancer; Lymph Node
• Interventions: Procedure: Immunochemistry and molecular biology on sentinel lymph node specimen

• Registration Number: NCT02861430
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Status Verified: 2016-08
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-05
• Study First Posted: 2016-08-10
• Primary Completion: 2017-03
• Study Completion: 2017-04
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Colectomy for Non metastatic colon cancer

Exclusion Criteria

• Tumor T4
• No medical insurance
• Pregnant woman
• Psychiatric disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Immunochemistry and molecular biology on sentinel lymph node specimen	-

Primary Outcome Measures

Name	Time	Method
Concordance between immunochemistry and molecular biology	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 Outcome Measures

Name	Time	Method
Disease-free survival	3 years

Trial Locations

Locations (1)

CHRU Besancon; 🇫🇷 Besancon, France