Assessing the Effect of a Blood-based Colorectal Cancer Screening Test on Screening Adherence and Colonoscopy Completion

NCT03598166 | Completed Results FDA Device

• 1 other identifier: MIRB 01683
• Study Type: interventional
• Target: 359
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: Colonoscopy and stool-based testing are the two predominant colorectal cancer (CRC) screening tests used in the US, and both reduce colorectal cancer mortality. However, only 62% of Americans are up to date with screening, partly because many individuals find these two tests inconvenient or unacceptable for a variety of reasons. There is an unmet need for a non-invasive test that does not require bowel preparation or handling stool, and the Septin9 DNA blood test may be an alternative for those individuals who would otherwise remain unscreened. Aims: Aim 1: To measure screening uptake with a blood test in screen-resistant patients who have declined both colonoscopy and fecal immunochemical testing (FIT) at the Manhattan VA Medical Center

• Sub-Aim 1a: To assess the proportion of those with a positive blood-based screening test who undergo diagnostic colonoscopy
• Sub-Aim 1b: To describe the endoscopic findings on diagnostic colonoscopy Aim 2: To survey screen-resistant patients to understand their beliefs and attitudes about colorectal cancer screening and testing options We hypothesize that a substantial proportion of patients who have refused colonoscopy and FIT will accept the blood test. We hypothesize this will be driven by the convenience of the blood test. Methods: This will be randomized controlled trial of individuals who have refused colonoscopy and FIT within past 6 months. Eligible patients will be randomized 1:1 to the intervention or control group. Both groups will be invited to participate in navigated colonoscopy or FIT by letter and telephone call. The intervention group will also be invited to participate in the blood test if they refuse colonoscopy and FIT. We will enroll 180 participants in each group (total n=360).

Conditions

Colorectal Cancer

Keywords

colorectal cancer screening; septin 9

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Undergo Screening Within 6 Months of Outreach

  Percentage of participants who undergo screening in the intervention group vs. control group, measured 6 months after the initial letter was sent

  6 months

Secondary Outcomes (5)

• Percentage of Participants Completing Screening Strategy

  12 months

• Percentage of Participants With Colonoscopy Follow-up in Intervention Group

  6 months (after positive FIT)

• Self-reported Willingness to Take Blood Test for Colorectal Cancer Screening on Questionnaire

  1 day (assessed using baseline survey)

• Self-reported Most Common Advantages of Blood Test on Questionnaire

  1 day (assessed using baseline survey)

• Self-reported Most Common Reasons for Refusing Blood Test on Questionnaire in Intervention Group

  1 day (assessed using baseline survey)

Study Arms (2)

Control

NO INTERVENTION

Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Patients who call will speak to a research assistant who is trained in patient navigation and can facilitate referrals for colonoscopy or FIT. Patients will receive a follow-up telephone call that reiterates information in the letter. Patients will also be asked to complete a questionnaire about their beliefs and attitudes regarding CRC screening. The questionnaire will be mailed with the invitation letter and will also be administered over the telephone by the research assistant.

Septin9

EXPERIMENTAL

Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Letters will also include an option to participate in the blood test, with instructions to call the study number to schedule the blood draw. This option will not appear in the letters sent to the control group. Patients will also receive a follow-up telephone call and a questionnaire. Participants who choose to the blood test (Septin9) will undergo phlebotomy. The blood sample will be run by an off-site commercial laboratory. The study team will notify patients and their primary care physicians of blood test results and will facilitate a colonoscopy referral for those with positive tests.

Diagnostic Test: Septin9

Interventions

Septin9 DIAGNOSTIC_TEST

Septin9 is a FDA-approved blood test for colorectal cancer screening

Also known as: Epi proColon, Epigenomics

Septin9

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• not up-to-date with colorectal cancer screening, defined as a colonoscopy in the past 10 years, a stool test (FOBT/FIT) in the past year, or a flexible sigmoidoscopy in the past 5 years.
• Declined colorectal cancer screening (both colonoscopy and FIT) in the previous 6 months, which must be documented in the electronic health record

You may not qualify if:

• Personal history of colonic adenomas (including sessile serrated adenomas), proximal hyperplastic polyps, CRC, inflammatory bowel disease, or hereditary gastrointestinal cancer syndrome
• First degree relative with CRC diagnosed at \<60 years of age; family history of hereditary gastrointestinal cancer syndromes.
• Vulnerable populations
• Adult unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

Sponsors & Collaborators

• Peter S. Liang, MD MPH: lead

Study Sites (1)

VA New York Harbor Health Care System

New York, New York, 10128, United States

Location

Related Publications (1)

• Liang PS, Zaman A, Kaminsky A, Cui Y, Castillo G, Tenner CT, Sherman SE, Dominitz JA. Blood Test Increases Colorectal Cancer Screening in Persons Who Declined Colonoscopy and Fecal Immunochemical Test: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2951-2957.e2. doi: 10.1016/j.cgh.2023.03.036. Epub 2023 Apr 8.

  PMID: 37037262 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Anika Zaman
• Organization: VA

anika.zaman@nyulangone.org

6464190648

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician

Model Details: Eligible patients will be randomized 1:1 to the intervention or control group

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 26, 2018
• Study Start: October 11, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 5, 2023
• Results First Posted: January 5, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)