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Trial record 34 of 54 for:    colon cancer | ( Map: Mississippi, United States )

Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)

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ClinicalTrials.gov Identifier: NCT02503696
Recruitment Status : Completed
First Posted : July 21, 2015
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

Brief Summary:
The primary objective of this study is to gather stool samples from subjects with inflammatory bowel disease (IBD) to be added to a test set of stool samples that will be utilized to help select molecular markers and determine the optimal sensitivity and specificity values for the Exact IBD-ACRN surveillance test for colorectal cancer (CRC).

Condition or disease Intervention/treatment
Inflammatory Bowel Disease Colorectal Neoplasms Digestive System Diseases Colonic Diseases Colorectal Cancer Device: Stool Collection Kit

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Study Type : Observational
Actual Enrollment : 697 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
Study Start Date : September 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : June 2016

Group/Cohort Intervention/treatment
IBD
Subjects will be men and women, 18-84 years of age, inclusive, who have been diagnosed with IBD. Each with a screening colonoscopy resulting in normal findings.
Device: Stool Collection Kit
Stool Collection Kit.




Primary Outcome Measures :
  1. Sensitivity and Specificity of the Exact CRC diagnostic screening test. [ Time Frame: 15 months ]
    The primary endpoint is point estimates of the sensitivity of the diagnostic test for detection of colorectal cancer in IBD patients.


Biospecimen Retention:   Samples With DNA
Provide anonymous, clinically characterized specimens for bio-repository for future colorectal cancer-related test development.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients are at risk of developing colorectal cancer at the time of their colonoscopy and the colonoscopy resulted in normal findings.
Criteria

Inclusion Criteria:

  • Male or Female 18 - 84 years of age, inclusive, who have been diagnosed with IBD.
  • Willing to provide a stool sample ≤120 but ≥7 days after a surveillance colonoscopy, which was negative for cancer/dysplasia.
  • Written informed consent document signed and dated by the subject.

Exclusion Criteria:

  • Any condition that in the opinion of the investigator should preclude participation in the study.
  • A history of aerodigestive tract cancer.
  • Prior colorectal resection, except ileocolic resection in Crohn's disease patients.
  • IBD limited only to the rectum.
  • Subject has participated in any clinical study within the previous 30 days wherein an investigational compound or device was, or may have been, introduced into the subject.

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): NCT02503696


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Sponsors and Collaborators
Exact Sciences Corporation
Investigators
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Study Chair: Graham Lidgard, PhD Exact Sciences

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Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT02503696     History of Changes
Other Study ID Numbers: 2014-05
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Exact Sciences Corporation:
Cancer
Colorectal Cancer
Neoplasm
Colorectal Neoplasm
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Inflammatory Bowel Disease
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

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