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Trial record 12 of 3555 for:    colon cancer AND Colonic Diseases

Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing

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ClinicalTrials.gov Identifier: NCT01600209
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : May 13, 2015
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

Tracking Information
First Submitted Date May 11, 2012
First Posted Date May 17, 2012
Last Update Posted Date May 13, 2015
Study Start Date October 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2013)
Sensitivity and Specificity of the Exact CRC diagnostic screening test. [ Time Frame: 10 months ]
The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.
Original Primary Outcome Measures
 (submitted: May 14, 2012)
Sensitivity and Specificity of the Exact CRC diagnostic screening test. [ Time Frame: 10 months ]
The diagnostic test under development is a multi-marker stool test for detecting CRC and pre-cancer in a general screening application. The primary objective of this study is to confirm the sensitivity of the optimal DNA marker panel. The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.
Change History Complete list of historical versions of study NCT01600209 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: May 14, 2012)
Collect stool samples from patients with normal findings identified during screening colonoscopy. [ Time Frame: 10 months ]
Residual samples from patients diagnosed with colorectal cancer will be archived for further research intended to help in the diagnosis of cancers.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing
Official Title Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing
Brief Summary The objective of this study is to confirm the sensitivity and specificity of a stool DNA test for detection of colorectal cancer and pre-cancer.
Detailed Description Patients who have recently undergone a colonoscopy that resulted with normal findings will be asked to submit a stool sample (s) (at least 30 days AFTER colonoscopy).
Study Type Observational
Study Design Observational Model: Case-Only
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 average risk of developing colorectal cancer at the time of their colonoscopy and the colonoscopy resulted in normal findings.
Condition
  • Colorectal Neoplasms
  • Digestive System Diseases
  • Colonic Diseases
  • Colorectal Cancer
Intervention Not Provided
Study Groups/Cohorts Average risk patients
Subjects will be men and women, 50-84 years of age, inclusive, each with a screening colonoscopy resulting in normal findings.
Publications * Lidgard GP, Domanico MJ, Bruinsma JJ, Light J, Gagrat ZD, Oldham-Haltom RL, Fourrier KD, Allawi H, Yab TC, Taylor WR, Simonson JA, Devens M, Heigh RI, Ahlquist DA, Berger BM. Clinical performance of an automated stool DNA assay for detection of colorectal neoplasia. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1313-8. doi: 10.1016/j.cgh.2013.04.023. Epub 2013 Apr 29.

*   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 11, 2012)
674
Original Estimated Enrollment
 (submitted: May 14, 2012)
600
Actual Study Completion Date September 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subject is male or female, 50-84 years of age, inclusive.
  • Subject is at average risk for development of CRC and has undergone a screening colonoscopy with a normal result at least 30 days and no more than 120 days before providing a stool sample for the study. For the purposes of this study, a "normal" colonoscopy result is defined as no polyps of any size detected or removed (including benign, hyperplastic polyps).
  • Subject is able to understand the study procedures, and is able to provide signed consent to participate in the study and authorizes release of relevant protected health information through signing a HIPAA consent.
  • Subject is able and willing to provide stool samples at least 30 days and no more than 120 days after undergoing a colonoscopy that resulted in normal findings, according to the written instructions provided to them.

Exclusion Criteria:

  • Subject has any condition which, in the opinion of the investigator should preclude participation in the study.
  • Subject had any findings on recent or any previous colonoscopy including benign, and/or hyperplastic polyps of any size. (Note: Tissue biopsies that result in no histopathology findings are acceptable.)
  • Subject has a history or recent diagnosis of CRC or adenoma.
  • Subject has a history of aerodigestive tract cancer.
  • Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
  • Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
  • Subject has had overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)
  • Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:

    • Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
    • Greater than or equal to (>=)2 first-degree relatives who have been diagnosed with colon cancer. (Note: first-degree relatives include parents, siblings and offspring).
    • One first-degree relative with CRC diagnosed before the age of 60.
    • Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP).
    • Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" of "Lynch Syndrome").
    • Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01600209
Other Study ID Numbers Exact Sciences 2011-N
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Exact Sciences Corporation
Study Sponsor Exact Sciences Corporation
Collaborators Not Provided
Investigators
Study Chair: Graham Lidgard, PhD Chief Scientific Officer
PRS Account Exact Sciences Corporation
Verification Date May 2015