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CompletedNCT02861430UNMASKUpdated Feb 11, 2025

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

An observational study in Colon Cancer, Lymph Node and Sentinel Node, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.

Sponsored by Centre Hospitalier Universitaire de Besancon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
48
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Colon Cancer
  • Lymph Node
  • Sentinel Node

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Keywords

  • colon cancer
  • sentinel node
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In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's enrollment of 48 is below the median of 280 across 349 observational studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Colon cancer

Inclusion criteria

  • Colectomy for Non metastatic colon cancer

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
48 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients

    Procedure: Immunochemistry and molecular biology on sentinel lymph node specimen

Interventions

  • ProcedureImmunochemistry and molecular biology on sentinel lymph node specimen
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month

Secondary outcomes

  1. Disease-free survival

    Time frame: 3 years

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Study locations

1 site
  • CHRU Besancon
    Besancon, 25030, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02861430
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Zaher Lakkis (MD, Centre Hospitalier Universitaire de Besancon) — Principal investigator
First posted
Aug 10, 2016
Start date
Apr 2014
Primary completion
Mar 2017
Completion
Apr 2017
Last update
Feb 11, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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