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Blood test could spot colon cancer in second round of screening

NCT ID NCT06880055

Diagnosis Sponsor: Guardant Health, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study looks at how well the Shield blood test finds colorectal cancer and advanced growths in people aged 45 to 81 who are at average risk. About 3,375 participants will take the test and then have a colonoscopy to compare results. The goal is to see if the blood test works well for a second round of screening.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 3,375 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects age 45 to 81 at average risk of CRC who meet inclusion, do not meet exclusion criteria, and who successfully enroll in the study

Ages

45 to 81 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects aged 45-81 years at time of consent 2. Intending to undergo a standard of care Shield test 3. Considered by a physician or healthcare provider as being of 'average risk' for CRC; 'Average-risk' individuals in the context of CRC screening are defined as those who do not have symptoms of CRC and do not have increased risk factors for the disease (i.e., prior diagnosis of CRC, adenomatous polyps, or inflammatory bowel disease; family history of CRC or known hereditary predisposition to CRC). 4. Subject agrees to comply with study procedures and associated standard of care assessments. Exclusion Criteria: 1. Undergoing colonoscopy for investigation of symptoms 2. Personal history of colorectal cancer (CRC), adenomas, or other related cancers 3. Family history of CRC, defined as having one or more first-degree relative (parent, sibling, or child) diagnosed with CRC at any age 4. Positive result on another colorectal cancer screening method within the last six months, or: * 12 months for fecal occult blood test (FOBT) or fecal immunochemical test (FIT) * 36 months for FIT-DNA test 5. 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), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis 6. Positive Shield test result within the previous 3 years 7. History of any malignancy (patients who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study) 8. Known diagnosis of inflammatory bowel disease 9. Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs (DMARDs) 10. Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent 11. Known medical condition which, in the opinion of the Investigator, should preclude enrollment into the study 12. Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy

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Conditions

The condition(s) this trial relates to.

colonic neoplasm colorectal cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colo-rectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    58 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alliance Research Institute, LLC

    RECRUITING

    Canoga Park, California, 91304, United States

  • Amicis Research Center

    RECRUITING

    Granada Hills, California, 91344, United States

  • Amicis Research Center

    RECRUITING

    Sherman Oaks, California, 91403, United States

  • Amicis Research Center

    RECRUITING

    Valencia, California, 91355, United States

  • Associated Gastroenterologists of Central New York

    RECRUITING

    Camillus, New York, 13031, United States

  • Associated Gastroenterologists of Central New York

    RECRUITING

    Fayetteville, New York, 13066, United States

  • Cary Gastroenterology Associates

    RECRUITING

    Cary, North Carolina, 27518, United States

  • Center for Digestive Disease

    RECRUITING

    Shenandoah, Texas, 77384, United States

  • Christie Clinic

    RECRUITING

    Champaign, Illinois, 61822, United States

  • Christie Clinic

    ACTIVE_NOT_RECRUITING

    Champaign, Illinois, 61822, United States

  • Coral Clinics

    RECRUITING

    Winnetka, California, 91306, United States

  • Desert Oasis Healthcare Medical Group

    RECRUITING

    Palm Springs, California, 92262, United States

  • Digestive Disease Associates

    RECRUITING

    Branford, Connecticut, 06405, United States

  • Digestive Disease Associates

    RECRUITING

    Branford, Connecticut, 06405, United States

  • Digestive Disease Consultants

    RECRUITING

    Bourbonnais, Illinois, 60914, United States

  • Digestive Disease Consultants

    RECRUITING

    Bourbonnais, Illinois, 60914, United States

  • Digestive Health Services

    RECRUITING

    Downers Grove, Illinois, 60515, United States

  • Digestive Health Services

    RECRUITING

    Downers Grove, Illinois, 60515, United States

  • Elite Primary Physicians, Inc.

    RECRUITING

    Anaheim, California, 92805, United States

  • Embassy Research Network

    RECRUITING

    Bloomfield Township, Michigan, 48302, United States

  • Florida South Research Phase I-IV, Inc.

    RECRUITING

    Miami, Florida, 33166, United States

  • GI Solutions of Illinois

    RECRUITING

    Chicago, Illinois, 60631, United States

  • GI Solutions of Illinois

    RECRUITING

    Chicago, Illinois, 60631, United States

  • GastroCare LI

    RECRUITING

    Valley Stream, New York, 11581, United States

  • GastroCare LI

    RECRUITING

    Valley Stream, New York, 11581, United States

  • Gastroenterology Associates of New Jersey

    ACTIVE_NOT_RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Gastroenterology Associates of New Jersey

    ACTIVE_NOT_RECRUITING

    Wayne, New Jersey, 07470, United States

  • Gastroenterology Associates of New Jersey, LLC

    RECRUITING

    Clifton, New Jersey, 07013, United States

  • Gastroenterology Associates of New Jersey, LLC

    RECRUITING

    Montclair, New Jersey, 07042, United States

  • Gastroenterology Associates of New Jersey, LLC

    RECRUITING

    Ridgewood, New Jersey, 07450, United States

  • Gastroenterology Associates of New Jersey, LLC

    RECRUITING

    Wayne, New Jersey, 07470, United States

  • Gastroenterology Consultants of Boca Raton, LLC

    RECRUITING

    Boca Raton, Florida, 33486, United States

  • Gastroenterology and Internal Medicine Specialists (GAIMS)

    RECRUITING

    Lake Barrington, Illinois, 60010, United States

  • Gastroenterology and Internal Medicine Specialists (GAIMS)

    RECRUITING

    Lake Barrington, Illinois, 60010, United States

  • Health Living at Pottstown Medical Specialists, Inc

    RECRUITING

    Pottstown, Pennsylvania, 19464, United States

  • Horizon Clinical Research Group

    RECRUITING

    Tomball, Texas, 77375, United States

  • Horizon Clinical Research Group

    RECRUITING

    Tomball, Texas, 77375, United States

  • Hutchinson Clinic

    ACTIVE_NOT_RECRUITING

    Hutchinson, Kansas, 67502, United States

  • Innova Pharma Research, LLC

    RECRUITING

    Doral, Florida, 33172, United States

  • Integrity Advanced Therapeutics, PLLC

    RECRUITING

    Houston, Texas, 77090, United States

  • Manuel Espinel MD PA

    RECRUITING

    Delray Beach, Florida, 33484, United States

  • Marisela Gonzalez, MD

    RECRUITING

    Miami, Florida, 33134, United States

  • NMC Research

    RECRUITING

    Tampa, Florida, 33607, United States

  • NYU Langone

    RECRUITING

    New York, New York, 10010, United States

  • Northlake Gastroenterology Associates

    RECRUITING

    Covington, Louisiana, 70433, United States

  • Northlake Gastroenterology Associates

    RECRUITING

    Hammond, Louisiana, 70403, United States

  • Northshore Center for Gastroenterology (NCG)

    RECRUITING

    Libertyville, Illinois, 60048, United States

  • Orchard Park Family Practice

    RECRUITING

    Orchard Park, New York, 14127, United States

  • Paragon Rx Clinical, Inc.

    WITHDRAWN

    Garden Grove, California, 92840, United States

  • Physicians Group of South Florida

    RECRUITING

    North Miami, Florida, 33181, United States

  • Piedmont Healthcare LLC

    ACTIVE_NOT_RECRUITING

    Statesville, North Carolina, 28625, United States

  • Piedmont Healthcare, P.A.

    ACTIVE_NOT_RECRUITING

    Mocksville, North Carolina, 27028, United States

  • Pinehurst Medical Clinic

    WITHDRAWN

    Pinehurst, North Carolina, 28374, United States

  • Premier Family Physicians

    ACTIVE_NOT_RECRUITING

    Austin, Texas, 78735, United States

  • Premier Family Physicians

    ACTIVE_NOT_RECRUITING

    Austin, Texas, 78746, United States

  • Quinn Healthcare, PLLC

    RECRUITING

    Ridgeland, Mississippi, 39157, United States

  • Research Associates of South Florida, LLC

    RECRUITING

    Miami, Florida, 33134, United States

  • Sanford Cardiology Pinehurst Medical Clinic

    WITHDRAWN

    Sanford, North Carolina, 27330, United States

  • Southeast Valley Gastroenterology Consultants

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Southeast Valley Gastroenterology Consultants

    RECRUITING

    Gilbert, Arizona, 85297, United States

  • Southwest Gastroenterology (SWG)

    RECRUITING

    Oak Lawn, Illinois, 60453, United States

  • Southwest Gastroenterology (SWG)

    RECRUITING

    Oak Lawn, Illinois, 60453, United States

  • Syracuse Gastroenterological Associates, P.C.

    RECRUITING

    East Syracuse, New York, 13057, United States

  • Tidewater Physician Multispecialty Group Clinical Research

    RECRUITING

    Williamsburg, Virginia, 23188, United States

  • US Digestive Health at Blair

    RECRUITING

    Altoona, Pennsylvania, 16602, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Hillsborough, North Carolina, 27278, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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