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Νew Molecular Biomarkers for the Prevention and Early Detection of Precancerous or Cancerous Colorectal Lesions During Screening for Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02596113
Recruitment Status : Recruiting
First Posted : November 4, 2015
Last Update Posted : November 4, 2015
Sponsor:
Collaborator:
National and Kapodistrian University of Athens
Information provided by (Responsible Party):
Nikos Viazis, Evangelismos Hospital

Brief Summary:
The investigators designed a prospective study to evaluate the predictive ability of detection of mutations in genes involved in carcinogenesis of the colon (eg hMLH1, K-Ras, B-Raf, ccfDNA) in a sample of Greek population presents for conducting colonoscopy in the context of screening under international CRC prevention instructions. This investigation will be carried out in individuals in normal risk in order to study specific mutations (in blood and tissue) to draw reliable conclusions about whether we can detect (with greater sensitivity and specificity) patients with precancerous lesions or CRC with a simple blood test thereby reducing the cost and side effects of repeated endoscopic procedures.

Condition or disease
Colorectal Cancer

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Νew Molecular Biomarkers for the Prevention and Early Detection of Precancerous or Cancerous Colorectal Lesions During Screening for Colorectal Cancer
Study Start Date : July 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Individuals without pathological findings during colonoscopy
In this group, sample would be collected from peripheral blood (plasma) and biopsy samples from normal colon mucosa
Individuals with bigger than 1 cm adenomatous polys
In this group, sample would be collected from peripheral blood (plasma) and biopsy samples from the polyp which would be sent for histopathological evaluation to confirm its adenomatous elements.
Individuals with colorectal cancer
In this group, sample would be collected from peripheral blood (plasma) and biopsy samples from colorectal cancer which would be sent for histopathological evaluation to confirm its cancerous elements.



Primary Outcome Measures :
  1. Genes' mutations rate in patients who are submitted screening colonoscopy and they presented with no endoscopic findings [ Time Frame: 1 month ]
  2. Genes' mutations rate in patients who are submitted screening colonoscopy and they presented with adenomatous polyp bigger than 1 cm [ Time Frame: 1 month ]
  3. Genes' mutations rate in patients who are submitted screening colonoscopy and they presented with cancerous lesion [ Time Frame: 1 month ]

Biospecimen Retention:   Samples With DNA
whole blood serum and colonic polyps tissue samples


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals in normal risk for developing CRC aged 50-75 years who undergo preventive colonoscopy for polyps and CRC detection
Criteria

Inclusion Criteria:

  • normal risk for developing CRC aged 50-75 years who undergo preventive colonoscopy for polyps and CRC detection

Exclusion Criteria:


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): NCT02596113


Contacts
Contact: Nikos Viazis, Director 00306977617000 nikos.viazis@gmail.com
Contact: Michalis Galanopoulos, Trainee 00306936619026 galanopoulosdr@gmail.com

Locations
Greece
Evangelismos Hospital Recruiting
Athens, Attiki, Greece, 10676
Contact: Nikos Viazis, Director    00306977617000    nikos.viazis@gmail.com   
Sub-Investigator: Michalis Galanopoulos, trainee/resident         
Sponsors and Collaborators
Evangelismos Hospital
National and Kapodistrian University of Athens
Investigators
Principal Investigator: Nikos Viazis, Director Evangelismos Hospital

Publications of Results:

Responsible Party: Nikos Viazis, Director Gastroenterology, Evangelismos Hospital
ClinicalTrials.gov Identifier: NCT02596113     History of Changes
Other Study ID Numbers: galanopoulosm
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: November 2015

Keywords provided by Nikos Viazis, Evangelismos Hospital:
colorectal cancer
genes involved in carcinogenesis of the colon
screening colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases