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

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ClinicalTrials.gov Identifier: NCT03598166
Recruitment Status : Enrolling by invitation
First Posted : July 25, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Liang, VA New York Harbor Healthcare System

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).


Condition or disease Intervention/treatment Phase
Colorectal Cancer Diagnostic Test: Septin9 Not Applicable

Detailed Description:

The proposed study is a randomized controlled trial that will 1) assess the uptake of a CRC screening blood test among patients who have declined both colonoscopy and FIT in the previous 6 months, including diagnostic evaluation of positive results and 2) survey patients about their beliefs and attitudes regarding CRC screening and testing options. All participants will be primary care patients at the Manhattan VA Medical Center. Based on a recent internal audit, there were 1502 patients who had at least one primary care visit from August 2016 through August 2017 and were not up to date with CRC screening. Up-to-date CRC screening is defined as either 1) a colonoscopy within the past 10 years or 2) FIT within the past year. We will perform an updated CRC screening audit at the beginning of the study to obtain the entire pool of eligible patients who are not up to date with screening. Eligible patients will then be randomized 1:1 to either an intervention group or a control group. All 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. Following the sequential testing approach, letters addressed to the intervention group will also include an option to participate in the blood test, with instructions to call the study number to schedule the blood draw. In addition to the letter, both groups will also receive a follow-up telephone call that reiterates information in the letter. The research assistant will make and receive all calls using a standard script. All patients will also be asked to complete a survey about their beliefs and attitudes regarding CRC screening. The survey will be mailed with the invitation letter and will also be administered over the telephone by the research assistant. 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. Primary care physicians will not be asked to notify the patients or make the colonoscopy referral because most will not have adequate knowledge of the Septin9 test to provide appropriate patient education.

Participants who are randomized to the blood test arm will undergo phlebotomy, which will be performed by the study research assistant. The blood sample will be temporarily stored on-site and then transported to an off-site commercial laboratory (Lenco Diagnostic Laboratory, Brooklyn, NY) to run the assay.

Clinical outcomes for both the intervention and control group participants will be measured as a secondary outcome. This includes timing and result of a screening colonoscopy or FIT for individuals in the controls group as well as diagnostic colonoscopy for participants who had a positive blood test.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible patients will be randomized 1:1 to the intervention or control group
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Assessing the Effect of Offering a Blood-based Colorectal Cancer Screening Test on Screening Adherence and Colonoscopy Completion in Patients Who Have Refused Colonoscopy and FIT
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control

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.

Experimental: Septin9

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
Septin9 is a FDA-approved blood test for colorectal cancer screening
Other Names:
  • Epi proColon
  • Epigenomics




Primary Outcome Measures :
  1. Proportion of participants who undergo screening within 6 months of outreach [ Time Frame: 6 months ]
    Proportion of participants who undergo screening in the intervention group vs. control group, measured 6 months after the initial letter was sent


Secondary Outcome Measures :
  1. Variables on self-reported questionnaire that predict acceptance of the blood test [ Time Frame: 1 day ]
    We will assess several demographic and health-related variables (e.g., age, sex, race, ethnicity, family history of colorectal cancer) to evaluate which are associated with acceptance of the blood test in the intervention group.

  2. Proportion of participants completing screening strategy [ Time Frame: 12 months ]
    Complete screening in both groups, which is defined as completion of the entire screening strategy. For colonoscopy, this requires cecal intubation and an adequate bowel preparation. For individuals who took Septin9 and FIT, positive results must be followed by a colonoscopy with cecal intubation and adequate bowel preparation.

  3. Proportion of participants with colonoscopy follow-up in intervention group [ Time Frame: 12 months ]
    Among individuals in the intervention group who had a positive blood test, proportion who completed a follow-up colonoscopy within 6 months.

  4. Proportion of participants with various colonoscopy findings in intervention group [ Time Frame: 12 months ]
    Endoscopic and pathologic findings among individuals in the intervention group who had a diagnostic colonoscopy (e.g., proportion of participants with polyp, adenoma, and cancer)

  5. Self-reported willingness to take blood test for colorectal cancer screening on questionnaire [ Time Frame: 1 day ]
    Proportion of both groups who answered that they would be willing to take a blood test for colorectal cancer screening

  6. Self-reported most common advantages of blood test on questionnaire [ Time Frame: 1 day ]
    The most commonly cited advantages of a blood test compared to colonoscopy and stool test in both groups

  7. Self-reported most common reasons for refusing blood test on questionnaire in intervention group [ Time Frame: 1 day ]
    The most commonly cited reasons for not taking the blood test in the intervention group.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598166


Locations
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United States, New York
VA New York Harbor Health Care System
New York, New York, United States, 10128
Sponsors and Collaborators
Peter Liang

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Responsible Party: Peter Liang, Staff Physician, VA New York Harbor Healthcare System
ClinicalTrials.gov Identifier: NCT03598166     History of Changes
Other Study ID Numbers: MIRB 01683
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Peter Liang, VA New York Harbor Healthcare System:
colorectal cancer screening
septin 9
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases