Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer

Completed

• Conditions: Colonic Diseases; Colorectal Cancer; Digestive System Diseases; Colorectal Neoplasms

• Registration Number: NCT01397747
• Lead Sponsor: Exact Sciences Corporation

Brief Summary

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.

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Primary Completion: 2013-02
• Study Completion: 2013-05
• Status Verified: 2015-11
• Results First Submitted: 2015-12-01
• Results First Submitted QC: 2015-12-01
• Last Update Submitted: 2015-12-01
• Results First Posted: 2015-12-03
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12776

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer.	90 Days	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).

Trial Locations

Locations (128)

Achieve Clinical Research; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Desert Sun Clinical Research, LLC; 🇺🇸 Tucson, Arizona, United States

HealthCare Partners; 🇺🇸 Pasadena, California, United States

Valley Gastro Consultants; 🇺🇸 Glendora, California, United States

Desert Oasis Healthcare; 🇺🇸 Palm Springs, California, United States

REMEK Research; 🇺🇸 Pomona, California, United States

Southern California Oncology; 🇺🇸 Yorba Linda, California, United States

HealthCare Partners Medical Group; 🇺🇸 Montebello, California, United States

Health Care Partners Medical Group; 🇺🇸 Torrance, California, United States

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