Deep-C Colorectal Cancer Screening Clinical Trial Completes EnrollmentExact Sciences Corporation has announced.
DeeP-C will evaluate stool DNA screening for colorectal cancer and high-risk precancerous lesions, comparing this method's efficacy with that of traditional screening tests among average-risk study participants age 50 to 84 years, the company reported.
The company's investigational DNA-based screening test detects genetic material shed from tumors and precancerous polyps in the colon lining. Patients collect a stool sample at home and mail it to a clinical laboratory for isolation of human DNA and identification of gene mutations associated with precancerous and cancerous colorectal cells.
“A patient-friendly test that detects cancer and advanced polyps early may well have a significant impact in the fight against colorectal cancer,” said principal investigator Thomas Imperiale, MD, professor of medicine and associate director for research at the Indiana University School of Medicine's gastroenterology division.
The study is “one of the largest and most scientifically rigorous colorectal cancer screening trials ever implemented,” Dr. Imperiale said.
Exact Sciences President and CEO Kevin T. Conroy described colorectal cancer as “the most preventable, yet least prevented cancer.”
“It is highly treatable if found early, but 40% of adults age 50 and older have not been screened as recommended,” Conroy noted.
The company's recently-completed 1,003-patient case-control study of stool DNA screening was presented at an October meeting of the American Association for Cancer Research (AACR). That study found that the DNA test detected 98% of colorectal cancers and up to 83% of ≥3 cm precancerous lesions with high-grade dysplasia.