Colorectal Cancer ScreeningNCT06929481
Screening With a DNA Blood Test to Address Colorectal Cancer Inequities
A study testing Cell free DNA (cfDNA) blood test and At home Fecal Immunochemical Test (FIT) or Colonoscopy in people with Colorectal Cancer Screening and Colorectal Cancer (CRC), run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening, Colorectal Cancer (CRC)
- What is being tested?
- Cell free DNA (cfDNA) blood test and At home Fecal Immunochemical Test (FIT) or Colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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:
- Hereditary non-polyposis colorectal cancer syndrome (HNPCC) or "Lynch Syndrome", Peutz-Jeghers Syndrome, MUTYH Polyposis (MAP), Familial Adenomatous Polyposis (FAP), Cowden's Syndrome, Juvenile Polyposis, Serrated Polyposis Syndrome
- Uninsured patients will be excluded because of inability to ensure follow up. Because of recently expanded Medi-Cal eligibility, exclusions due to insurance are expected to be minimal.
Trial locations and contacts
1 site in 1 country.
United States1 site
Family Health Centers of San Diego, Logan Heights site
San Diego, California, 92113
About this study
Official title: Screening With Liquid Biopsies to Address Colorectal Cancer Inequities
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.
Read the detailed description
Patients assigned to usual care will be offered options for screening using a standardized script outlining: 1) importance of screening; 2) option of screening with at home FIT or colonoscopy, including key characteristics. Description of key characteristics will include 1) test completion steps; 2) test performance, stating that colonoscopy picks up 9 out of 10 colorectal cancers and important growths called polyps, and that FIT picks up 3 in 4 cancers and 1 in 4 important polyps (we define "important polyps" as adenomas 1 centimeter or larger in size or containing villous/tubulovillous histology or high-grade dysplasia). The script will note abnormal FIT requires a colonoscopy to check for CRC and important growths. Patients assigned to the intervention group will receive an identical offer, but with additional option of screening with an in clinic cfDNA plus an at home FIT. The script will state cfDNA is a blood test meant to be complementary to current screening with ability to detect 8 out of 10 CRCs and 1 in 10 important polyps, and offers advantage of having a same day test for CRC detection to complement the FIT that they will do at home. The script will also state colonoscopy is required if either cfDNA or FIT is abnormal. For patients who opt for the cfDNA plus at home FIT option, the study team will coordinate same day blood draw. Following manufacturer's instructions, 40 mL of blood (4 tubes each with 10 mL of blood) will be collected and sent to Guardant Health for the Guardant Shield test. Patients will be instructed to complete the FIT as soon as possible and within 5 days, and, to minimize the influence of cfDNA result on likelihood of FIT completion, cfDNA results will not be disclosed to the patient for 14 days after the clinic visit. For all subjects, demographic characteristics, coded data on primary provider of record, and outcomes will be collected. Because this is planned as a pragmatic trial to mimic the potential impact of introducing the cfDNA test into usual care, and because the study poses minimum risk and promotes potentially lifesaving colorectal cancer screening, a waiver of informed consent for study screening and randomization to study group assignment, and for written documentation of informed consent has been approved. An informed consent sheet with the option to "opt out" of the study will be provided to all potential subjects.
- Being tested
- Cell free DNA (cfDNA) blood test, At home Fecal Immunochemical Test (FIT) or Colonoscopy
- Keywords
- cfDNA, cell free DNA blood test, CRC screening, colorectal cancer screening, colorectal cancer inequities, Family Health Centers of San Diego, FHCSD, Guardant Health
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell free DNA (cfDNA) blood testDevice
Also called cfDNA, cfDNA blood test, Guardant Shield cfDNA test, Guardant Shield test
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.
At home Fecal Immunochemical Test (FIT) or ColonoscopyOther
Also called at home FIT or colonoscopy
The usual care group will be offered standard colorectal cancer screening options to choose from: at home FIT or colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: At home Fecal Immunochemical Test (FIT) or Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 meeting inclusion criteria 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.
Measured: 60 Days
Secondary outcomes (7)
Screening completion with dual completion
Proportion of people enrolled meeting inclusion criteria who complete a colorectal cancer screening test within 60 days of enrollment defined by:
- For the usual care group, number of people who completed screening/total number of people included in the study confirmed to meet inclusion criteria;
- For the intervention group, number of people who completed screening/total number of people included in the study confirmed to meet inclusion criteria, where number completing screening for people choosing cell free DNA plus a fecal immunochemical test requires completion of both tests.
Measured: 60 days
Screening test order at baseline
Proportion of people enrolled meeting inclusion criteria with a screening test order, defined by:
Number of people with a screening test order/total number of people included in the study confirmed to meet inclusion criteria
Measured: 1 day
Screening test selection at baseline
Proportion of people enrolled meeting inclusion criteria selecting colonoscopy, fecal immunochemial test (FIT), or cell free DNA plus a FIT as their screening option, defined by:
- For the usual care group: i. number of people who selected FIT/total number of people included in the study confirmed to meet inclusion criteria ii. number of people who selected colonoscopy/total number of people included in the study confirmed to meet inclusion criteria b) For the intervention group: iii. number of people who selected FIT/total number of people included in the study confirmed to meet inclusion criteria iv. number of people who selected colonoscopy/total number of people included in the study confirmed to meet inclusion criteria v. number of people who selected cfDNA plus a fecal immunochemical test/total number of people included in the study confirmed to meet inclusion criteria
Measured: 1 day
Colonoscopy referral
Number of people with an abnormal fecal immunochemical test or cell free DNA test with colonoscopy referral
Measured: Within 90 days of abnormal cell free DNA or fecal immunochemical test result
Colonoscopy scheduling
Number of people with an abnormal fecal immunochemical test or cell free DNA test with colonoscopy scheduling
Measured: Within 90 days of abnormal cell free DNA or fecal immunochemical test
Colonoscopy completion
Number of people with an abnormal fecal immunochemical test or cell free DNA test with colonoscopy completion
Measured: Within 90 days of abnormal cell free DNA or fecal immunochemical test result
Colonoscopy findings
Number and type of colonoscopy findings among those people with an abnormal cell free DNA or fecal immunochemical test result
Measured: Within 90 days of abnormal cell free DNA or fecal immunochemical test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start28 Apr 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- CUREBOUND, INC., Family Health Centers of San Diego
- Responsible party
- Principal investigator, Samir Gupta, University of California, San Diego
- Investigators
- Samir Gupta, MD, MSCS, AGAF, Principal investigator, University of California, San DiegoJob G Godino, PhD, Principal investigator, Family Health Centers of San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929481
- Sponsor's protocol ID
- 811489
- Other IDs
- 316051-00001
- Status last verified
- Jun 2026
- First submitted
- 16 Mar 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The trial results will be submitted for peer review publication. A limited, de-identified dataset for replication of analyses will be made available upon request to the corresponding author, and with execution of a data use agreement, if permitted by the human subjects protection programs at UCSD and FHCSD.
Publications
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.
PubMed 23921906Singal 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.
PubMed 26535565Gupta 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.
PubMed 27481306Singal 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.
PubMed 28873161Lieberman 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.
PubMed 31387970Lieberman 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.
PubMed 34230556Castaneda 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.
PubMed 37802222Arredondo 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.
PubMed 32202155De 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.
PubMed 32466687Castaneda 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.
PubMed 32078353Bharti 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.
PubMed 31479529Mohl 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.
PubMed 36652246Ciemins 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.
PubMed 38526494Shareef 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.
PubMed 38554066Ladabaum 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.
PubMed 38552670
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening With Liquid Biopsies to Address Colorectal Cancer Inequities
- ClinicalTrials.gov ID
- NCT06929481
- Acronym / sponsor ID
- 811489
- Keywords
- cfDNA, cell free DNA blood test, CRC screening, colorectal cancer screening, colorectal cancer inequities, Family Health Centers of San Diego, FHCSD, Guardant Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- CUREBOUND, INC., Family Health Centers of San Diego
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients assigned to usual care will be offered options for screening using a standardized script outlining: 1) importance of screening; 2) option of screening with at home FIT or colonoscopy, including key characteristics. Description of key characteristics will include 1) test completion steps; 2) test performance, stating that colonoscopy picks up 9 out of 10 colorectal cancers and important growths called polyps, and that FIT picks up 3 in 4 cancers and 1 in 4 important polyps (we define "important polyps" as adenomas 1 centimeter or larger in size or containing villous/tubulovillous histology or high-grade dysplasia). The script will note abnormal FIT requires a colonoscopy to check for CRC and important growths. Patients assigned to the intervention group will receive an identical offer, but with additional option of screening with an in clinic cfDNA plus an at home FIT. The script will state cfDNA is a blood test meant to be complementary to current screening with ability to detect 8 out of 10 CRCs and 1 in 10 important polyps, and offers advantage of having a same day test for CRC detection to complement the FIT that they will do at home. The script will also state colonoscopy is required if either cfDNA or FIT is abnormal. For patients who opt for the cfDNA plus at home FIT option, the study team will coordinate same day blood draw. Following manufacturer's instructions, 40 mL of blood (4 tubes each with 10 mL of blood) will be collected and sent to Guardant Health for the Guardant Shield test. Patients will be instructed to complete the FIT as soon as possible and within 5 days, and, to minimize the influence of cfDNA result on likelihood of FIT completion, cfDNA results will not be disclosed to the patient for 14 days after the clinic visit. For all subjects, demographic characteristics, coded data on primary provider of record, and outcomes will be collected. Because this is planned as a pragmatic trial to mimic the potential impact of introducing the cfDNA test into usual care, and because the study poses minimum risk and promotes potentially lifesaving colorectal cancer screening, a waiver of informed consent for study screening and randomization to study group assignment, and for written documentation of informed consent has been approved. An informed consent sheet with the option to "opt out" of the study will be provided to all potential subjects.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Cell free DNA (cfDNA) blood test, Other: At home Fecal Immunochemical Test (FIT) or ColonoscopyParticipants 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. |
| Usual Care Group | Active comparator | Other: At home Fecal Immunochemical Test (FIT) or ColonoscopyParticipants randomized to the usual care group will be offered standard colorectal cancer screening options: at home FIT or colonoscopy. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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:
- Abnormal FIT, FOBT, cfDNA, FIT-DNA, or FIT-RNA test within the last 3 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cell free DNA (cfDNA) blood testAlso: cfDNA, cfDNA blood test, Guardant Shield cfDNA test, Guardant Shield testThe 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. | Device | Intervention Group |
| At home Fecal Immunochemical Test (FIT) or ColonoscopyAlso: at home FIT or colonoscopyThe usual care group will be offered standard colorectal cancer screening options to choose from: at home FIT or colonoscopy. | Other | Intervention Group, Usual Care Group |
Primary outcome
Screening completion
Time frame: 60 Days
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 meeting inclusion criteria 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.
7 secondary outcomes
Screening completion with dual completion
Time frame: 60 days
Screening test order at baseline
Time frame: 1 day
Screening test selection at baseline
Time frame: 1 day
Colonoscopy referral
Time frame: Within 90 days of abnormal cell free DNA or fecal immunochemical test result
Colonoscopy scheduling
Time frame: Within 90 days of abnormal cell free DNA or fecal immunochemical test
Colonoscopy completion
Time frame: Within 90 days of abnormal cell free DNA or fecal immunochemical test result
Colonoscopy findings
Time frame: Within 90 days of abnormal cell free DNA or fecal immunochemical test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 23921906Gupta 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.
- Background: PubMed 26535565Singal 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.
- Background: PubMed 27481306Gupta 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.
- Background: PubMed 28873161Singal 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.
- Background: PubMed 31387970Lieberman 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.
- Background: PubMed 34230556Lieberman 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.
- Background: PubMed 37802222Castaneda 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.
- Background: PubMed 32202155Arredondo 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.
- Background: PubMed 32466687De 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.
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- Individual participant dataSharing planned: No. The trial results will be submitted for peer review publication. A limited, de-identified dataset for replication of analyses will be made available upon request to the corresponding author, and with execution of a data use agreement, if permitted by the human subjects protection programs at UCSD and FHCSD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Gupta, MD, MSCS, AGAF principal investigator
University of California, San Diego
Job G Godino, PhD principal investigator
Family Health Centers of San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell free DNA (cfDNA) blood test and At home Fecal Immunochemical Test (FIT) or Colonoscopy in people with Colorectal Cancer Screening and Colorectal Cancer (CRC), run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening completion (time frame: 60 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06929481, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.