Screening With a DNA Blood Test to Address Colorectal Cancer Inequities

NCT06929481 | Enrolling By Invitation FDA Device

• 2 other identifiers: 811489316051-00001
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer (CRC) screening participation is suboptimal and associated with inequities in CRC outcomes by race/ethnicity and socioeconomic position. A novel, cell free DNA (cfDNA) blood test has potential to increase participation, but has not been studied in groups at highest risk for adverse CRC outcomes. Among patients age-eligible for colorectal cancer screening, not up-to-date, we propose a 2-arm, pragmatic, randomized controlled trial comparing offers of standard screening options (at home fecal immunochemical test (FIT) or colonoscopy) vs. offers of expanded options (at home FIT, colonoscopy, or in clinic cfDNA plus at home FIT), set at a large Federally Qualified Health Center serving individuals at increased risk for inequities in CRC outcomes. Results will inform guideline and policy makers on whether cfDNA should be supported as a screening option, and support planning for a large-scale trial examining impact of a cfDNA option for screening on CRC and advanced neoplasia detection.

Conditions

Colorectal Cancer Screening; Colorectal Cancer (CRC)

Keywords

cfDNA; cell free DNA blood test; CRC screening; colorectal cancer screening; colorectal cancer inequities; Family Health Centers of San Diego; FHCSD; Guardant Health

Outcome Measures

Primary Outcomes (1)

• Screening completion

  A single primary outcome measure, screening completion within 60 days of enrollment, is planned. The outcome measure will be defined as the proportion of people enrolled who complete a colorectal cancer screening test within 60 days of enrollment. The definition of colorectal cancer screening test completion includes exposure to a fecal immunochemical test, colonoscopy, or cell free DNA test. The outcome measure will be computed for the standard versus expanded option groups, and compared via a chi-squared test of proportions.

  60 Days

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants randomized to the intervention group will be offered expanded colorectal cancer screening options: at home FIT, colonoscopy, or additional option of an in clinic FDA-approved cfDNA blood test with at home FIT.

Device: Cell free DNA (cfDNA) blood test; Other: At home Fecal Immunochemical Test (FIT) or Colonoscopy

Usual Care Group

ACTIVE COMPARATOR

Participants randomized to the usual care group will be offered standard colorectal cancer screening options: at home FIT or colonoscopy.

Other: At home Fecal Immunochemical Test (FIT) or Colonoscopy

Interventions

Cell free DNA (cfDNA) blood test DEVICE

The intervention is a novel blood test that evaluates circulating cell free tumor DNA (cfDNA) and detects colorectal cancer (CRC). Recently, the cfDNA test has been shown to have 83% sensitivity and 90% specificity for CRC detection, and 13% sensitivity for advanced polyp detection, heralding a new screening strategy postulated to be highly convenient and acceptable. The cfDNA test is made by Guardant Health, FDA approved for average risk colorectal cancer screening, and marketed with the brand name "Shield". Patients opting for the cfDNA test will also be requested to complete an at home FIT.

Also known as: cfDNA, cfDNA blood test, Guardant Shield cfDNA test, Guardant Shield test

Intervention Group

At home Fecal Immunochemical Test (FIT) or Colonoscopy OTHER

The usual care group will be offered standard colorectal cancer screening options to choose from: at home FIT or colonoscopy.

Also known as: at home FIT or colonoscopy

Intervention Group; Usual Care Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons, aged 45 to 75 years old
• Not up-to-date with screening, defined based on an existing electronic health record (EHR)-based flag that indicates absence of FIT within the last 12 months, colonoscopy within the last 10 years, sigmoidoscopy within the last 5 years or multi-target stool DNA (Cologuard) test within 3 years.
• Attending primary care visits during the 2 months of recruitment. According to routine practice, screening status will be confirmed by primary care providers as part of routine visits.
• Being provided the informed consent form.

You may not qualify if:

• Personal history of colorectal cancer (CRC), adenomas, or other related cancers.
• Prior history of colorectal surgery
• Family history of CRC, defined as having one or more first-degree relative (parent, sibling, or child) diagnosed with CRC at any age.
• Up-to-date with colorectal cancer screening, defined as:
• Fecal occult blood test (FOBT) or FIT within the last 12 months
• FIT-DNA (Cologuard) or FIT-RNA (Colosense) test within 3 years
• cfDNA (Shield) within the last year
• CT colonography within the last 5 years
• Sigmoidoscopy within the last 5 years
• Colonoscopy within the last 10 years
• Abnormal FIT, FOBT, cfDNA, FIT-DNA, or FIT-RNA test within the last 3 years.
• 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
• Familial adenomatous polyposis (FAP)
• Other hereditary cancer syndromes including but not limited to:

Sponsors & Collaborators

• University of California, San Diego: lead
• CUREBOUND, INC.: collaborator
• Family Health Centers of San Diego: collaborator

Study Sites (1)

Family Health Centers of San Diego, Logan Heights site

San Diego, California, 92113, United States

Location

Related Publications (19)

• Gupta S, Halm EA, Rockey DC, Hammons M, Koch M, Carter E, Valdez L, Tong L, Ahn C, Kashner M, Argenbright K, Tiro J, Geng Z, Pruitt S, Skinner CS. Comparative effectiveness of fecal immunochemical test outreach, colonoscopy outreach, and usual care for boosting colorectal cancer screening among the underserved: a randomized clinical trial. JAMA Intern Med. 2013 Oct 14;173(18):1725-32. doi: 10.1001/jamainternmed.2013.9294.

  PMID: 23921906 BACKGROUND

• Singal AG, Gupta S, Tiro JA, Skinner CS, McCallister K, Sanders JM, Bishop WP, Agrawal D, Mayorga CA, Ahn C, Loewen AC, Santini NO, Halm EA. Outreach invitations for FIT and colonoscopy improve colorectal cancer screening rates: A randomized controlled trial in a safety-net health system. Cancer. 2016 Feb 1;122(3):456-63. doi: 10.1002/cncr.29770. Epub 2015 Nov 4.

  PMID: 26535565 BACKGROUND

• Gupta S, Miller S, Koch M, Berry E, Anderson P, Pruitt SL, Borton E, Hughes AE, Carter E, Hernandez S, Pozos H, Halm EA, Gneezy A, Lieberman AJ, Sugg Skinner C, Argenbright K, Balasubramanian B. Financial Incentives for Promoting Colorectal Cancer Screening: A Randomized, Comparative Effectiveness Trial. Am J Gastroenterol. 2016 Nov;111(11):1630-1636. doi: 10.1038/ajg.2016.286. Epub 2016 Aug 2.

  PMID: 27481306 BACKGROUND

• Singal AG, Gupta S, Skinner CS, Ahn C, Santini NO, Agrawal D, Mayorga CA, Murphy C, Tiro JA, McCallister K, Sanders JM, Bishop WP, Loewen AC, Halm EA. Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial. JAMA. 2017 Sep 5;318(9):806-815. doi: 10.1001/jama.2017.11389.

  PMID: 28873161 BACKGROUND

• Lieberman A, Gneezy A, Berry E, Miller S, Koch M, Ahn C, Balasubramanian BA, Argenbright KE, Gupta S. Financial Incentives to Promote Colorectal Cancer Screening: A Longitudinal Randomized Control Trial. Cancer Epidemiol Biomarkers Prev. 2019 Nov;28(11):1902-1908. doi: 10.1158/1055-9965.EPI-19-0039. Epub 2019 Aug 6.

  PMID: 31387970 BACKGROUND

• Lieberman A, Gneezy A, Berry E, Miller S, Koch M, Argenbright KE, Gupta S. The effect of deadlines on cancer screening completion: a randomized controlled trial. Sci Rep. 2021 Jul 6;11(1):13876. doi: 10.1038/s41598-021-93334-1.

  PMID: 34230556 BACKGROUND

• Castaneda SF, Gupta S, Nodora JN, Largaespada V, Roesch SC, Rabin BA, Covin J, Ortwine K, Preciado-Hidalgo Y, Howard N, Halpern MT, Martinez ME. Hub-and-Spoke centralized intervention to optimize colorectal cancer screening and follow-up: A pragmatic, cluster-randomized controlled trial protocol. Contemp Clin Trials. 2023 Nov;134:107353. doi: 10.1016/j.cct.2023.107353. Epub 2023 Oct 5.

  PMID: 37802222 BACKGROUND

• Arredondo EM, Dumbauld J, Milla M, Madanat H, Coronado GD, Haughton J, Garcia-Bigley F, Ramers C, Nodora J, Bharti B, Lopez G, Diaz M, Marquez J, Gupta S. A Promotor-Led Pilot Study to Increase Colorectal Cancer Screening in Latinos: The Juntos Contra El Cancer Program. Health Promot Pract. 2021 Jul;22(4):491-501. doi: 10.1177/1524839920912240. Epub 2020 Mar 22.

  PMID: 32202155 BACKGROUND

• De La Torre CL, Dumbauld JN, Haughton J, Gupta S, Nodora J, Giacinto RE, Ramers C, Bharti B, Wells K, Lopez J, Diaz M, Moody J, Arredondo EM. Development of a Group-Based Community Health Worker Intervention to Increase Colorectal Cancer Screening Among Latinos. Hisp Health Care Int. 2021 Mar;19(1):47-54. doi: 10.1177/1540415320923564. Epub 2020 May 29.

  PMID: 32466687 BACKGROUND

• Castaneda SF, Bharti B, Rojas M, Mercado S, Bearse AM, Camacho J, Lopez MS, Munoz F, O'Connell S, Liu L, Talavera GA, Gupta S. Outreach and Inreach Strategies for Colorectal Cancer Screening Among Latinos at a Federally Qualified Health Center: A Randomized Controlled Trial, 2015-2018. Am J Public Health. 2020 Apr;110(4):587-594. doi: 10.2105/AJPH.2019.305524. Epub 2020 Feb 20.

  PMID: 32078353 BACKGROUND

• Bharti B, May FFP, Nodora J, Martinez ME, Moyano K, Davis SL, Ramers CB, Garcia-Bigley F, O'Connell S, Ronan K, Barajas M, Gordon S, Diaz G, Ceja E, Powers M, Arredondo EM, Gupta S. Diagnostic colonoscopy completion after abnormal fecal immunochemical testing and quality of tests used at 8 Federally Qualified Health Centers in Southern California: Opportunities for improving screening outcomes. Cancer. 2019 Dec 1;125(23):4203-4209. doi: 10.1002/cncr.32440. Epub 2019 Sep 3.

  PMID: 31479529 BACKGROUND

• Mohl JT, Ciemins EL, Miller-Wilson LA, Gillen A, Luo R, Colangelo F. Rates of Follow-up Colonoscopy After a Positive Stool-Based Screening Test Result for Colorectal Cancer Among Health Care Organizations in the US, 2017-2020. JAMA Netw Open. 2023 Jan 3;6(1):e2251384. doi: 10.1001/jamanetworkopen.2022.51384.

  PMID: 36652246 BACKGROUND

• Ciemins EL, Mohl JT, Moreno CA, Colangelo F, Smith RA, Barton M. Development of a Follow-Up Measure to Ensure Complete Screening for Colorectal Cancer. JAMA Netw Open. 2024 Mar 4;7(3):e242693. doi: 10.1001/jamanetworkopen.2024.2693.

  PMID: 38526494 BACKGROUND

• Shareef F, Bharti B, Garcia-Bigley F, Hernandez M, Nodora J, Liu J, Ramers C, Nery JD, Marquez J, Moyano K, Rojas S, Arredondo E, Gupta S. Abnormal Colorectal Cancer Test Follow-Up: A Quality Improvement Initiative at a Federally Qualified Health Center. J Prim Care Community Health. 2024 Jan-Dec;15:21501319241242571. doi: 10.1177/21501319241242571.

  PMID: 38554066 BACKGROUND

• Ladabaum U, Mannalithara A, Weng Y, Schoen RE, Dominitz JA, Desai M, Lieberman D. Comparative Effectiveness and Cost-Effectiveness of Colorectal Cancer Screening With Blood-Based Biomarkers (Liquid Biopsy) vs Fecal Tests or Colonoscopy. Gastroenterology. 2024 Jul;167(2):378-391. doi: 10.1053/j.gastro.2024.03.011. Epub 2024 Mar 26.

  PMID: 38552670 BACKGROUND

• Lieberman DA; AGA CRC Workshop Panel. Commentary: Liquid Biopsy for Average-Risk Colorectal Cancer Screening. Clin Gastroenterol Hepatol. 2024 Jun;22(6):1160-1164.e1. doi: 10.1016/j.cgh.2024.01.034. Epub 2024 Mar 26. No abstract available.

  PMID: 38552672 BACKGROUND

• Coronado GD, Jenkins CL, Shuster E, Johnson C, Amy D, Cook J, Sahnow S, Zepp JM, Mummadi R. Blood-based colorectal cancer screening in an integrated health system: a randomised trial of patient adherence. Gut. 2024 Mar 7;73(4):622-628. doi: 10.1136/gutjnl-2023-330980.

  PMID: 38176899 BACKGROUND

• Chung DC, Gray DM 2nd, Singh H, Issaka RB, Raymond VM, Eagle C, Hu S, Chudova DI, Talasaz A, Greenson JK, Sinicrope FA, Gupta S, Grady WM. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):973-983. doi: 10.1056/NEJMoa2304714.

  PMID: 38477985 BACKGROUND

• Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023 May-Jun;73(3):233-254. doi: 10.3322/caac.21772. Epub 2023 Mar 1.

  PMID: 36856579 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Hematologic Tests; Colonoscopy

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Samir Gupta, MD, MSCS, AGAF

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Job G Godino, PhD

  Family Health Centers of San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: April 16, 2025
• Study Start: April 28, 2025
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)