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

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: NCT01260168
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : May 13, 2015
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

Brief Summary:

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.


Condition or disease
Colorectal Neoplasms Digestive System Diseases Colonic Diseases Colorectal Cancer

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 435 participants
Observational Model: Case-Only
Official Title: Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
Study Start Date : October 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Group/Cohort
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.



Primary Outcome Measures :
  1. The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms. [ Time Frame: 12 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.


Secondary Outcome Measures :
  1. To collect samples from patients diagnosed with colorectal cancers. [ Time Frame: 12 Months ]
    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.


Biospecimen Retention:   Samples With DNA
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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have had colorectal cancer or pre-malignancy confirmed by colonoscopic biopsy-based diagnosis.
Criteria

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.

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): NCT01260168


Locations
Show Show 21 study locations
Sponsors and Collaborators
Exact Sciences Corporation
Investigators
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Study Chair: Graham Lidgard, PhD Chief Scientific Officer

Publications of Results:
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Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT01260168    
Other Study ID Numbers: Exact Sciences 2010-A
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015
Keywords provided by Exact Sciences Corporation:
Cancer
Colorectal Cancer
Neoplasm
Colorectal Neoplasm
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Additional relevant MeSH terms:
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Colorectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Neoplasms
Digestive System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Intestinal Diseases
Rectal Diseases