NCT02861430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

February 11, 2025

Status Verified

August 1, 2016

Enrollment Period

2.9 years

First QC Date

August 2, 2016

Last Update Submit

February 10, 2025

Conditions

Colon CancerLymph NodeSentinel Node

Keywords

colon cancersentinel node

Outcome Measures

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.

    1 month

Secondary Outcomes (1)

  • Disease-free survival

    3 years

Study Arms (1)

Patients

Procedure: Immunochemistry and molecular biology on sentinel lymph node specimen

Interventions

Immunochemistry and molecular biology on sentinel lymph node specimenPROCEDURE
Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Colon cancer

You may qualify if:

  • Colectomy for Non metastatic colon cancer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Besancon

Besançon, 25030, France

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 10, 2016

Study Start

April 1, 2014

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

February 11, 2025

Record last verified: 2016-08

Locations

FR(1)