Expression of DMBT1 in Colorectal Cancer Patients (DMBT1)

September 12, 2016 updated by: Lille Catholic University

Modification of the Expression and the Localization of DMBT1 (Deleted in Malignant Brain Tumor 1) in Colorectal Cancer

Although colorectal cancer is a preventable and curable disease if early stage tumors are removed, it is still the fourth cause of cancer worldwide and the second leading cause of death in many industrialized countries. The 5-year survival is about 55% often due to a late detection. Then, the identification of sensitive and specific molecular markers is therefore a major challenge for early diagnosis and prognosis of this disease.

Preliminary work have reported variations in the expression of DMBT1 (deleted in malignant brain tumor 1), a glycoprotein co-secreted with mucins in the light of the glands, during several stages of colon carcinogenesis. The goal of this study is to study by mass spectrometry (MS), alterations in the repertoire of glycosylation of mucins from colorectal tumors of various stages, grades, and recurrence status.

Study Overview

Study Type

Observational

Enrollment (Actual)

145

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals with colorectal carcinoma, with polyps or without colonic pathology

Description

Inclusion Criteria:

  • for colon cancer: patients surgically treated for colorectal cancer at the Group of hospitals of the Catholic Institute of Lille.
  • for adenomatous polyps : patients treated for adenomatous polyps at the Group of hospitals of the Catholic Institute of Lille.
  • for controls: patients surgically treated for diverticular disease at the Group of hospitals of the Catholic Institute of Lille.

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with colorectal cancer
Fresh tissue samples from individuals with colorectal carcinoma taken from the tumor as well as from resection margins will be used for the detection of a potential marker of carcinogenesis.
Patients with adenomatous polyps
Fresh tissue samples from individuals with adenomatous polyps will be used for the detection of a potential marker of carcinogenesis.
Control patients
Fresh tissue samples from individuals without colorectal carcinoma will be used as control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semi-quantitative determination of the histological expression of DMBT1
Time Frame: at baseline
The expression of DMTB1 will be determined by observation of the slides after immunohistochemistry using an anti-DMBT1 antibody
at baseline
Determination of the histological localisation of DMBT1
Time Frame: at baseline
The localisation of DMTB1 will be determined by observation of slides after immunohistochemistry using an anti-DMBT1 antibody
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Adriana Mihalache, MD, PhD, GHICL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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