Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01260168
First received: December 6, 2010
Last updated: November 13, 2013
Last verified: May 2013

December 6, 2010
November 13, 2013
October 2010
November 2013   (final data collection date for primary outcome measure)
The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
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. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01260168 on ClinicalTrials.gov Archive Site
To collect samples from patients diagnosed with colorectal cancers. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Residual samples from patients diagnosed with colorectal cancer will be archived for further research intended to help in the diagnosis of cancers. Specimens will be stored up to 10 years in the Sponsor's on-site bio-repository or similar commercial bio-repository contracted by the sponsor.
To collect samples from patients diagnosed with colorectal cancers. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Residual samples from patients diagnosed with colorectal cancer will be archived for further research intended to help in the diagnosis of cancers. Specimens will be stored up to 10 years in the Sponsor's on-site bio-repository or similar commercial bio-repository contracted by the Sponsor.
Not Provided
Not Provided
 
Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies

The objective of this study is to confirm the sensitivity of a stool DNA test for detection of colorectal cancer and pre-cancer.

Another objective is to provide anonymous, clinically characterized specimens for a bio-repository for future colorectal cancer-related test development.

Patients who have been recently diagnosed with colo-rectal cancer or pre-cancer will be asked to submit a stool sample(s)(at least 7 days AFTER colonoscopy) and will have the option of submitting blood and tissue samples for future colo-rectal cancer-related test development.

Observational
Observational Model: Case-Only
Not Provided
Retention:   Samples With DNA
Description:

Residual specimens and histopathology tissue slides or blocks will be stored for up to 10 years in the Sponsor's on-site bio-repository or similar commercial bio-repository contracted by the Sponsor.

Non-Probability Sample

Patients who have had colorectal cancer or pre-malignancy confirmed by colonoscopic biopsy-based diagnosis.

  • Colorectal Neoplasms
  • Digestive System Diseases
  • Colonic Diseases
  • Colorectal Cancer
Not Provided
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 an intact pre-malignant colorectal lesion large enough to require surgical excision or complex colonoscopic polypectomy.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
435
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject is male or female, 40-90 years of age, inclusive.
  2. Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy and/or ≥1 cm colorectal polyp/adenoma/mass identified on a colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.
  3. Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

  1. Subject has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).
  2. Subject has a history of any inflammatory bowel disease.
  3. Subject has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.
  4. 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.
Both
40 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01260168
Exact Sciences 2010-A
No
Exact Sciences Corporation
Exact Sciences Corporation
Not Provided
Study Chair: Graham Lidgard, PhD Chief Scientific Officer
Exact Sciences Corporation
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP