This clinical trial compares a mailed stool DNA test (Cologuard) versus mailed fecal immunochemical test (FIT) in determining the optimal early colorectal cancer screening for patients aged 45-49. Colorectal cancer (CRC) accounts for 8% of cancer incidence and 9% of cancer-related death in the United States (US). About 11% of CRC cases are diagnosed before age 50 — known as early age onset CRC (EOCRC). The incidence of EOCRC has increased 1.6% and 1% per year between 2005-2014, with an unequal burden among Asian, American Indian/Alaska Native, Black and Hispanic racial/ethnic groups and those with Medicaid or uninsured. Because of this, the US Preventive Services Task Force has recommended starting CRC screening in average risk adults at age 45 rather than 50. A FIT test uses a small sample of stool placed in a special collection tube or on a special card to check for occult (hidden) blood in the stool. Blood in the stool may be a sign of colorectal cancer or other problems, such as polyps, ulcers, or hemorrhoids. Colon tumor cells may have DNA changes in certain genes. The presence of abnormal cells or blood in the stool may indicate cancer or precancer tumors. Cologuard also uses a stool sample, but checks for these genetic changes. Previous studies have found that patients prefer FIT testing compared to colonoscopy. The Cologuard test may be more effective than FIT given its direct-to-patient mailing of the test, personalized customer service that includes facilitation and reminders for test completion, high sensitivity for finding cancers (93% versus [vs.] 74% for FIT), and only requiring follow-up every three years for a normal finding, rather than yearly. This trial may help doctors determine the best CRC screening strategy (Cologuard vs. FIT) for patients age 45-49.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06931860.
Locations matching your search criteria
United States
California
La Jolla
UC San Diego Moores Cancer CenterStatus: Active
Contact: Joshua Demb
Phone: 858-822-3747
PRIMARY OBJECTIVES:
I. To identify an optimal CRC screening outreach strategy for adults ages 45-49 that maximizes uptake and minimizes disparities and inequities.
II. Interview participants and providers about factors influencing CRC screening uptake. (Aim 1)
III. Conduct pilot trial of comparative effectiveness of mailed Cologuard outreach vs. mailed FIT outreach screening strategies among adults ages 45-49 to establish feasibility of larger trial. (Aim 2)
IV. Conduct pragmatic randomized controlled trial of comparative effectiveness of mailed Cologuard outreach vs. mailed FIT outreach screening strategies among adults ages 45-49.
OUTLINE:
AIM 1: Participants complete interviews on study.
AIM 2: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive Cologuard test shipped directly their home, with 2 months of personalized support to facilitate screening completion included. Patients complete the Cologuard test and return sample via mail. Patients with normal results are sent a notification of their test results via MyChart with recommendation to repeat CRC screening in 3 years. Patients with abnormal results are sent a notification of their test results via MyChart and recommendation to schedule follow up colonoscopy.
ARM II: Patients receive FIT test shipped directly their home and receive reminders via phone about 14 days and 28 days after FIT kit receipt. Patients complete the FIT test and return sample via mail. Patients with normal results are sent a notification of their test results via MyChart with recommendation to repeat CRC screening in 1 year. Patients with abnormal results are sent a notification of their test results via MyChart and recommendation to schedule follow up colonoscopy.
AIM 3: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive Cologuard test shipped directly their home, with 2 months of personalized support to facilitate screening completion included. Patients complete the Cologuard test and return sample via mail. Patients with normal results are sent a notification of their test results via MyChart with recommendation to repeat CRC screening in 3 years. Patients with abnormal results are sent a notification of their test results via MyChart and recommendation to schedule follow up colonoscopy.
ARM II: Patients receive FIT test shipped directly their home and receive reminders via phone about 14 days and 28 days after FIT kit receipt. Patients complete the FIT test and return sample via mail. Patients with normal results are sent a notification of their test results via MyChart with recommendation to repeat CRC screening in 1 year. Patients with abnormal results are sent a notification of their test results via MyChart and recommendation to schedule follow up colonoscopy.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUC San Diego Moores Cancer Center
Principal InvestigatorJoshua Demb
