Trial record 1 of 1 for:    Deep-C
Previous Study | Return to List | Next Study

Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer (DeeP-C)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01397747
First received: July 18, 2011
Last updated: December 1, 2015
Last verified: November 2015
  Purpose

The primary objective is to determine the sensitivity and specificity of the Exact Colorectal Cancer (CRC) screening test for colorectal cancer, using colonoscopy as the reference method. Lesions will be confirmed as malignant by histopathologic examination.

The secondary objective is to compare the performance of the Exact CRC screening test to a commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.


Condition
Colorectal Neoplasms
Digestive System Diseases
Colonic Diseases
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer: DeeP-C Study

Resource links provided by NLM:


Further study details as provided by Exact Sciences Corporation:

Primary Outcome Measures:
  • Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer. [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The DNA test includes quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and Beta-actin, plus a hemoglobin immunoassay. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. FIT values of more than 100 ng of hemoglobin per milliliter of buffer were considered to be positive. Tests were processed independently of colonoscopic findings. The test functions as a screening tool by generating a score, based on the detection of hemoglobin and multiple DNA methylation and mutational markers, together with an assessment of the total amount of human DNA in each sample. Sensitivity= 100*(multitarget DNA or FIT positive test/positive colonoscopy); Specificity= 100*(multitarget DNA or FIT negative test/negative colonoscopy).


Biospecimen Retention:   Samples With DNA
Residual stool samples may be archived for further research. Clinical data and samples will be kept in a manner that preserves anonymity of the subjects, using the subject ID as the only tracking information. Specimens will be stored in a commercial biorepository contracted by Exact Sciences or at Exact Sciences and may be used for future research.

Enrollment: 12776
Study Start Date: June 2011
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Average risk patients
Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer.

Detailed Description:
Patients who are at average risk of developing colorectal cancer who are eligible for colorectal cancer screening will be asked to collect a single stool sample for the Exact CRC screening test and for the commercially available FIT assay. Subjects will undergo colonoscopy within 90 days of enrollment. Representative histopathology slides from tissue biopsied or excised during colonoscopy and representative histopathology slides resulting from subsequent definitive surgery may be retrieved in order to be evaluated by central pathology to confirm diagnosis and staging.
  Eligibility

Ages Eligible for Study:   50 Years to 84 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients at average risk of developing colorectal cancer.
Criteria

Inclusion Criteria:

  1. Subject is average risk for development of colorectal cancer (as defined by the inclusion and exclusion criteria below).
  2. Subject is able and willing to undergo a screening colonoscopy within 90 days of enrollment.
  3. Subject is 50 to 84 years of age inclusive.
  4. Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
  5. Subject is able and willing to provide stool samples according to written instructions provided to them.

Exclusion Criteria:

  1. Subject has any condition which, in the opinion of the investigator should preclude participation in the study.
  2. Subject has undergone colonoscopy within the previous nine (9) years.
  3. Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
  4. Subject has a history of colorectal cancer or adenoma.
  5. Subject has a history of aerodigestive tract cancer.
  6. Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
  7. Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
  8. 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).
  9. 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.
    • >= 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.
  10. Subject has a family history of:

    • Familial adenomatous polyposis (also referred to as "FAP").
    • Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
  11. Participation in any "interventional" clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397747

  Show 185 Study Locations
Sponsors and Collaborators
Exact Sciences Corporation
Investigators
Principal Investigator: Thomas Imperiale, MD Principal Study Investigator
  More Information

Publications:
Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT01397747     History of Changes
Other Study ID Numbers: Exact Sciences 2011-01 
Study First Received: July 18, 2011
Results First Received: December 1, 2015
Last Updated: December 1, 2015
Health Authority: United States: Food and Drug Administration

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:
Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Adenomatous Polyps
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Intestinal Diseases
Rectal Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 29, 2016