NCT01647776

Brief Summary

The investigators propose a screening population-based study to systematically evaluate the accuracy and clinical relevance of sDNA testing as a potential alternative to colonoscopy screening. In addition, the investigators propose a genetic epidemiologic study of the relation between colon polyps, an established precursor of colon cancer, and two factors that may influence risk for colon cancer: candidate genes and diet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 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, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2016

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

3.4 years

First QC Date

July 5, 2012

Last Update Submit

February 8, 2021

Conditions

Colon Cancer

Keywords

Colon NeoplasiaColorectal carcinomacolon cancercolon polypcolonoscopysDNA testFIT tests (fecal immunochemical test)relating colon neoplasia to obesity, type 2 diabetescolonoscopy and pathology confirmed advanced adenomas

Outcome Measures

Primary Outcomes (2)

  • Stool DNA (sDNA) Feasibility and Compliance

    For this aim, we will recruit a sub-sample of the study participants to perform the sDNA test for aberrantly methylated markers in addition to their colonoscopy to assess willingness to participate, compliance with test protocol and patient satisfaction to determine potential for a larger study to evaluate the effectiveness of this test for detection of colon adenomas.

    within 12 weeks prior to the colonoscopy

  • Efficacy of sDNA testing for the detection of advanced adenomas

    For the sDNA test aims, the primary goals are to assess the sensitivity and specificity of sDNA testing for the detection of advanced adenomas, and to compare the performance of the Exact sDNA Panel with that of FIT. The sensitivity and specificity of sDNA and FIT will be estimated based on the concordance and discordance of advanced adenomas detected against that of colonoscopy as the gold standard

    prior to the colonoscopy

Secondary Outcomes (9)

  • Concordance/discordance between tissue and stool DNA aberrant methylation markers

    Stool sample within 2 weeks of colonoscopy

  • Persistence of positive sDNA testing after removal of advanced adenomas

    at 12 months after initial colonoscopy

  • Assess the frequency of missed or occult colonic and upper gastrointestinal neoplasia in patients with initially normal colonoscopies and persistently positive sDNA testing.

    at 12 months after initial colonoscopy

  • Insulin Resistance Syndrome

    at the time of the colonoscopy

  • Analyses stratified by ethnicity (Caucasians versus African Americans), and gender.

    at the time of the colonoscopy

  • +4 more secondary outcomes

Study Arms (2)

Individuals without colon polyps

Other: Stool DNA TestProcedure: biopsies of rectal and colon mucosaOther: Questionnaires

Individuals with colon polyps

Other: Stool DNA TestProcedure: biopsies of rectal and colon mucosaOther: Questionnaires

Interventions

Stool DNA TestOTHER

Stool DNA test is done prior to the colonoscopy.

Also known as: sDNA
Individuals with colon polypsIndividuals without colon polyps
biopsies of rectal and colon mucosaPROCEDURE

During the standard of care colonoscopy biopsies of rectal and colon mucosa will be taken for analysis of 15-PGDH pathway factors \[levels of prostaglandin E2 (PG E2), and mRNA for 15-PGDH, COX-1 and COX-2 expression\] as markers of risk of developing adenoma.

Individuals with colon polypsIndividuals without colon polyps
QuestionnairesOTHER

A Food Frequency Questionnaire (FFQ), a Meat Preparation Questionnaire (MPQ), and a Physical Activity Questionnaire (PAQ), all developed at the University of Arizona Cancer Center will be used to collect dietary and physical activity data. Risk Factor Questionnaire (RFQ) developed by the University of Southern California will be used to collect general risk information. Stool (sDNA) test patient satisfaction survey.

Also known as: Food Frequency Questionnaire (FFQ), Meat Preparation Questionnaire (MPQ), Physical Activity Questionnaire (PAQ), Risk Factor Questionnaire (RFQ)
Individuals with colon polypsIndividuals without colon polyps

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Average-risk patients undergoing colonoscopy at screening endoscopy centers in the University Hospitals of Cleveland system.

You may qualify if:

  • patients undergoing routine colonoscopy at University Hospitals, Cleveland Ohio

You may not qualify if:

  • Unable to give written consents
  • Unable to fill the questionnaires
  • A history of polyps within the past 10 years (except hyperplastic polyps)
  • Family history of Familial Adenomatous Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC)
  • Personal history of inflammatory bowel disease
  • Personal diagnosis of any cancer, with the exception of non-melanoma skin cancer
  • Any major colon surgeries (e.g. resectioning)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, Urine, Stool samples, Colon polyps

MeSH Terms

Conditions

Colonic NeoplasmsColorectal NeoplasmsColonic PolypsDiabetes Mellitus, Type 2

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesIntestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Joseph E Willis, MD

    University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2012

First Posted

July 24, 2012

Study Start

April 1, 2012

Primary Completion

August 11, 2015

Study Completion

August 11, 2016

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

US(1)