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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Zaher Lakkis, 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.

Condition or disease Intervention/treatment
Colon Cancer Lymph Node Sentinel Node Procedure: Immunochemistry and molecular biology on sentinel lymph node specimen

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Study Type : Observational
Estimated Enrollment : 388 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Patients Procedure: Immunochemistry and molecular biology on sentinel lymph node specimen



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Disease-free survival [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Colon cancer
Criteria

Inclusion Criteria:

  • Colectomy for Non metastatic colon cancer

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
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Contact: Zaher Lakkis, MD +00 33 637968298 zlakkis@chu-besancon.fr

Locations
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France
CHRU Besancon Recruiting
Besancon, France, 25030
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
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Responsible Party: Zaher Lakkis, MD, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02861430    
Other Study ID Numbers: Besancon Unmask
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Keywords provided by Zaher Lakkis, Centre Hospitalier Universitaire de Besancon:
colon cancer
sentinel node
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases