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Trial record 68 of 126 for:    colon cancer AND Rectal | ( Map: New Jersey, United States )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 17, 2015
First Posted Date July 21, 2015
Last Update Posted Date August 10, 2016
Study Start Date September 2014
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2015)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02503696 on ClinicalTrials.gov Archive Site
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 Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
Official Title Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Provide anonymous, clinically characterized specimens for bio-repository for future colorectal cancer-related test development.
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.
Condition
  • Inflammatory Bowel Disease
  • Colorectal Neoplasms
  • Digestive System Diseases
  • Colonic Diseases
  • Colorectal Cancer
Intervention Device: Stool Collection Kit
Stool Collection Kit.
Study Groups/Cohorts 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.
Intervention: Device: Stool Collection Kit
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: August 9, 2016)
697
Original Estimated Enrollment
 (submitted: July 17, 2015)
600
Actual Study Completion Date June 2016
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States,   Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02503696
Other Study ID Numbers 2014-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Exact Sciences Corporation
Study Sponsor Exact Sciences Corporation
Collaborators Not Provided
Investigators
Study Chair: Graham Lidgard, PhD Exact Sciences
PRS Account Exact Sciences Corporation
Verification Date August 2016