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Expression of DMBT1 in Colorectal Cancer Patients (DMBT1)

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ClinicalTrials.gov Identifier: NCT02901600
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Lille Catholic University

Tracking Information
First Submitted Date September 12, 2016
First Posted Date September 15, 2016
Last Update Posted Date September 15, 2016
Study Start Date June 2013
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 12, 2016)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Expression of DMBT1 in Colorectal Cancer Patients
Official Title Modification of the Expression and the Localization of DMBT1 (Deleted in Malignant Brain Tumor 1) in Colorectal Cancer
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals with colorectal carcinoma, with polyps or without colonic pathology
Condition
  • DMBT1 Protein, Human
  • Colorectal Cancer
Intervention Other: Detection of the expression of DMTB1 by immunohistochemistry
Study Groups/Cohorts
  • 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.
    Intervention: Other: Detection of the expression of DMTB1 by immunohistochemistry
  • Patients with adenomatous polyps
    Fresh tissue samples from individuals with adenomatous polyps will be used for the detection of a potential marker of carcinogenesis.
    Intervention: Other: Detection of the expression of DMTB1 by immunohistochemistry
  • Control patients
    Fresh tissue samples from individuals without colorectal carcinoma will be used as control.
    Intervention: Other: Detection of the expression of DMTB1 by immunohistochemistry
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 12, 2016)
145
Original Actual Enrollment Same as current
Actual Study Completion Date November 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02901600
Other Study ID Numbers RT-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Lille Catholic University
Study Sponsor Lille Catholic University
Collaborators Not Provided
Investigators
Principal Investigator: Adriana Mihalache, MD, PhD GHICL
PRS Account Lille Catholic University
Verification Date September 2016