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Trial record 8 of 3796 for:    colon cancer AND Intestinal Neoplasms

Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers

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ClinicalTrials.gov Identifier: NCT02503631
Recruitment Status : Terminated (Changes in development plan)
First Posted : July 21, 2015
Last Update Posted : April 6, 2018
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 April 6, 2018
Actual Study Start Date October 2014
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 21, 2016)
To provide stool and blood specimens to assess new markers for the detection of CRC [ Time Frame: 33 months ]
Original Primary Outcome Measures
 (submitted: July 17, 2015)
To provide stool specimens to assess new markers for the detection of CRC [ Time Frame: 33 months ]
Change History Complete list of historical versions of study NCT02503631 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 21, 2016)
  • To provide stool and blood specimens for use as controls when assessing new markers for the detection of neoplasms in other locations within the digestive tract (esophagus, stomach, pancreas, etc.) [ Time Frame: 33 months ]
  • To provide stool and blood specimens for a biorepository for future cancer-related diagnostic test development [ Time Frame: 33 months ]
  • To provide quality control material for use in assessing performance of developed assays [ Time Frame: 33 months ]
Original Secondary Outcome Measures
 (submitted: July 17, 2015)
  • To provide stool specimens for use as controls when assessing new markers for the detection of neoplasms in other locations within the digestive tract (esophagus, stomach, pancreas, etc.) [ Time Frame: 33 months ]
  • To provide stool specimens for a biorepository for future cancer-related diagnostic test development [ Time Frame: 33 months ]
  • To provide quality control material for use in assessing performance of developed assays [ Time Frame: 33 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
Official Title Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
Brief Summary The primary objective of this study is to obtain de-identified, clinically characterized, stool and plasma specimens for use in assessing new markers for the detection of neoplasms of the digestive tract.
Detailed Description

This is a multi-site, prospective sample collection study. Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of CRC and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.

One stool sample from approximately 300 subjects will be collected in this study. A blood sample will also be collected from subjects.

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 and blood samples for bio-repository for future colorectal cancer-related test development.
Sampling Method Non-Probability Sample
Study Population Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of CRC and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.
Condition
  • Colorectal Neoplasms
  • Digestive System Diseases
  • Colonic Diseases
  • Colorectal Cancer
Intervention Device: Stool Sample Collection Kit
Stool sample collection kit
Study Groups/Cohorts Colorectal cancer patients
Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of colorectal cancer (CRC) and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.
Intervention: Device: Stool Sample 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 Terminated
Actual Enrollment
 (submitted: April 4, 2018)
397
Original Estimated Enrollment
 (submitted: July 17, 2015)
300
Actual Study Completion Date September 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subject is male or female, 40-90 years of age, inclusive.
  • Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or colorectal polyp/adenoma/mass that is equal or larger than 1 cm in pre-enrollment colonoscopy with residual lesion in the colon of sufficient size to require additional surgical excision or complex colonoscopic polypectomy.
  • Subject understands the study procedures and is able to provided informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

  • Subject has actively bleeding hemorrhoids (blood on toilet paper or bright red blood clots in the toilet bowel during bowel movement).
  • Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02503631
Other Study ID Numbers 2014-02
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: Michael Domanico Exact Sciences
PRS Account Exact Sciences Corporation
Verification Date April 2018