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RecruitingAccepts healthy volunteers

Shield Post-Approval Study Protocol

Guardant Health, Inc. · NCT06880055

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 45–81 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
3375
US sites recruiting
58
Study start
July 14, 2025
Record last updated
August 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The Shield post-approval study (PAS) is a prospective, longitudinal study supplemented with Real World Evidence (RWE) to evaluate the longitudinal performance of Shield in an average risk population at a second round of testing for individuals between the ages of 45 and 81 at average risk of CRC using colonoscopy as the reference method.

Being studied: Shield Blood Test for colo-rectal cancer Screening

Conditions: Colo-rectal Cancer

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Subjects aged 45-81 years at time of consent
  • Intending to undergo a standard of care Shield test
  • 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).
  • Subject agrees to comply with study procedures and associated standard of care assessments.

Exclusion Criteria

  • Undergoing colonoscopy for investigation of symptoms
  • Personal history of colorectal cancer (CRC), adenomas, or other related cancers
  • Family history of CRC, defined as having one or more first-degree relative (parent, sibling, or child) diagnosed with CRC at any age
  • 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
  • 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
  • Positive Shield test result within the previous 3 years
  • 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)
  • Known diagnosis of inflammatory bowel disease
  • Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs (DMARDs)
  • 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
  • Known medical condition which, in the opinion of the Investigator, should preclude enrollment into the study
  • 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

Recruiting US locations

  • Southeast Valley Gastroenterology Consultants

    Chandler, AZ 85224

    Site contact: Charles Schron · 480-899-2994 · cmsphoenix@aol.com

  • Southeast Valley Gastroenterology Consultants

    Gilbert, AZ 85297

    Site contact: Charles Schron · 480-899-2994 · cmsphoenix@aol.com

  • Elite Primary Physicians, Inc.

    Anaheim, CA 92805

    Site contact: Brandon Bonilla · 818-924-4708 · b.bonilla@amicisresearch.com

  • Alliance Research Institute, LLC

    Canoga Park, CA 91304

    Site contact: Victor Odogwu · 818-835-9085 · vodogwu@allianceri.org

  • Amicis Research Center

    Granada Hills, CA 91344

    Site contact: Tyrone Rosales · 818-924-4708 · tyrone.rosales@amicisresearch.com

  • Desert Oasis Healthcare Medical Group

    Palm Springs, CA 92262

    Site contact: Brooke Yates · 760-320-9505 · byates@mydohc.com

  • Amicis Research Center

    Sherman Oaks, CA 91403

    Site contact: William Calder · 818-464-4870 · w.calder@amicisresearch.com

  • Amicis Research Center

    Valencia, CA 91355

    Site contact: Veronica Macias · 818-639-8822 · veronica.macias@amicisresearch.com

  • Coral Clinics

    Winnetka, CA 91306

    Site contact: William Calder · 818-924-4708 · w.calder@amicisresearch.com

  • Digestive Disease Associates

    Branford, CT 06405

    Site contact: Lillian Urrutia · 561-453-3215 · Lurrutia@yanuvia.com

  • Digestive Disease Associates

    Branford, CT 06405

    Site contact: Alan Bernegger · 920-472-1093 · abernegger@yanuvia.com

  • Gastroenterology Consultants of Boca Raton, LLC

    Boca Raton, FL 33486

    Site contact: Lillian Urrutia · 561-453-3215 · Lurrutia@yanuvia.com

  • Manuel Espinel MD PA

    Delray Beach, FL 33484

    Site contact: Kristell Vazquez · 561-501-4646 · kristell.vazquez92@gmail.com

  • Innova Pharma Research, LLC

    Doral, FL 33172

    Site contact: Mario Llobet · 305-200-5646 · mllobet@innovapresearch.com

  • Marisela Gonzalez, MD

    Miami, FL 33134

    Site contact: Milagros Fernandez · 305-220-3700 · mfernandez@mariselagonzalezmdpa.net

  • Research Associates of South Florida, LLC

    Miami, FL 33134

    Site contact: Stephany Moreno · 786-476-8790 · smoreno@researchassociatesfl.com

  • Florida South Research Phase I-IV, Inc.

    Miami, FL 33166

    Site contact: Lisbelle Revoredo · 305-418-0847 · Lrevoredo@southfloridatrials.com

  • Physicians Group of South Florida

    North Miami, FL 33181

    Site contact: Daniel Wolfson · 305-609-1349 · danielwolfson1126@yahoo.com

  • NMC Research

    Tampa, FL 33607

    Site contact: Jose Martinez · 813-374-0568 · jmartinez@nmc-research.com

  • Digestive Disease Consultants

    Bourbonnais, IL 60914

    Site contact: Hussain Boxwalla · 708-860-7866 · hboxwalla@avicennaclinical.com

  • Digestive Disease Consultants

    Bourbonnais, IL 60914

    Site contact: Hussain Boxwalla · (708) 860-7866 · hboxwalla@avicennaclinical.com

  • Christie Clinic

    Champaign, IL 61822

    Site contact: Andrew Bartlett · 217-366-1331 · abartlett@christieclinic.com

  • GI Solutions of Illinois

    Chicago, IL 60631

    Site contact: Hussain Boxwalla · 708-860-7866 · hboxwalla@avicennaclinical.com

  • GI Solutions of Illinois

    Chicago, IL 60631

    Site contact: Hussain Boxwalla · (708) 860-7866 · hboxwalla@avicennaclinical.com

  • Digestive Health Services

    Downers Grove, IL 60515

    Site contact: Hussain Boxwalla · 708-860-7866 · hboxwalla@avicennaclinical.com

  • Digestive Health Services

    Downers Grove, IL 60515

    Site contact: Hussain Boxwalla · (708) 860-7866 · hboxwalla@avicennaclinical.com

  • Gastroenterology and Internal Medicine Specialists (GAIMS)

    Lake Barrington, IL 60010

    Site contact: Hussain Boxwalla · 708-860-7866 · hboxwalla@avicennaclinical.com

  • Gastroenterology and Internal Medicine Specialists (GAIMS)

    Lake Barrington, IL 60010

    Site contact: Hussain Boxwalla · (708) 860-7866 · hboxwalla@avicennaclinical.com

  • Northshore Center for Gastroenterology (NCG)

    Libertyville, IL 60048

    Site contact: Hussain Boxwalla · (708) 860-7866 · hboxwalla@avicennaclinical.com

  • Southwest Gastroenterology (SWG)

    Oak Lawn, IL 60453

    Site contact: Hussain Boxwalla · 708-860-7866 · hboxwalla@avicennaclinical.com

  • Southwest Gastroenterology (SWG)

    Oak Lawn, IL 60453

    Site contact: Hussain Boxwalla Chief Operating Officer/Owner · (708) 860-7866 · hboxwalla@avicennaclinical.com

  • Northlake Gastroenterology Associates

    Covington, LA 70433

    Site contact: Alan Bernegger · 920-472-1093 · abernegger@yanuvia.com

  • Northlake Gastroenterology Associates

    Hammond, LA 70403

    Site contact: Alan Bernegger · 920-472-1093 · abernegger@yanuvia.com

  • Embassy Research Network

    Bloomfield Township, MI 48302

    Site contact: Zander Minano · 248-622-4083 · zminano@embassyresearch.com

  • Quinn Healthcare, PLLC

    Ridgeland, MS 39157

    Site contact: Khadijra Lockwood · 601-487-6482 · Khadijra.lockwood@roviaclinical.com

  • Gastroenterology Associates of New Jersey, LLC

    Clifton, NJ 07013

    Site contact: Alan Bernegger · 920-472-1093 · abernegger@yanuvia.com

  • Gastroenterology Associates of New Jersey, LLC

    Montclair, NJ 07042

    Site contact: Alan Bernegger · 920-472-1093 · abernegger@yanuvia.com

  • Gastroenterology Associates of New Jersey, LLC

    Ridgewood, NJ 07450

    Site contact: Alan Bernegger · 920-472-1093 · abernegger@yanuvia.com

  • Gastroenterology Associates of New Jersey, LLC

    Wayne, NJ 07470

    Site contact: Alan Bernegger · 920-472-1093 · abernegger@yanuvia.com

  • Associated Gastroenterologists of Central New York

    Camillus, NY 13031

    Site contact: Alan Bernegger · 920-472-1093 · abernegger@yanuvia.com

  • Syracuse Gastroenterological Associates, P.C.

    East Syracuse, NY 13057

    Site contact: Alan Bernegger · 920-472-1093 · abernegger@yanuvia.com

  • Associated Gastroenterologists of Central New York

    Fayetteville, NY 13066

    Site contact: Alan Bernegger · 920-472-1093 · abernegger@yanuvia.com

  • NYU Langone

    New York, NY 10010

    Site contact: Anika Zaman · (212) 686-7500 ext 15745 · anika.zaman@nyulangone.org

  • Orchard Park Family Practice

    Orchard Park, NY 14127

    Site contact: Elizabeth Swanson · 716-339-3666 · swanson@circuitclinical.com

  • GastroCare LI

    Valley Stream, NY 11581

    Site contact: Alan Bernegger · 920-472-1093 · abernegger@yanuvia.com

  • GastroCare LI

    Valley Stream, NY 11581

    Site contact: Alan Bernegger · 920-472-1093 · abernegger@yanuvia.com

  • Cary Gastroenterology Associates

    Cary, NC 27518

    Site contact: Alan Bernegger · 920-472-1093 · abernegger@yanuvia.com

  • University of North Carolina at Chapel Hill

    Chapel Hill, NC 27514

    Site contact: Shilpa Karanjit · 919-843-8519 · shilpa_karanjit@med.unc.edu

  • University of North Carolina at Chapel Hill

    Chapel Hill, NC 27599

    Site contact: Shilpa Karanjit · 919-843-8519 · shilpa_karanjit@med.unc.edu

  • University of North Carolina at Chapel Hill

    Hillsborough, NC 27278

    Site contact: Shilpa Karanjit · 919-843-8519 · shilpa_karanjit@med.unc.edu

  • US Digestive Health at Blair

    Altoona, PA 16602

    Site contact: Amanda Bianconi · 814-946-5469 · abianconi@usdhealth.com

  • University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Alexis Winters · 215-349-8222 · alexis.winters@pennmedicine.upenn.edu

  • Health Living at Pottstown Medical Specialists, Inc

    Pottstown, PA 19464

    Site contact: Stacy Cowden · 610-858-9174 · scowden@circuitclinical.com

  • Integrity Advanced Therapeutics, PLLC

    Houston, TX 77090

    Site contact: Scott Ward · 281-453-2005 · scott.ward@iat.care

  • Center for Digestive Disease

    Shenandoah, TX 77384

    Site contact: Melissa Clark · 936-321-5440 · melissa.clark@cddgastro.net

  • Horizon Clinical Research Group

    Tomball, TX 77375

    Site contact: Shatabdi Satpathi · 281-803-9960 · shatabdi@horizoncrg.com

  • Horizon Clinical Research Group

    Tomball, TX 77375

    Site contact: Shatabdi Satpathi · 281-803-9960 · shatabdi@horizoncrg.com

  • Tidewater Physician Multispecialty Group Clinical Research

    Williamsburg, VA 23188

    Site contact: Gabrielle Land · 757-707-3503 · gabrielle.land@tpmgpc.com

Study contacts (from the official record)

  • Hannah Oakley · 415-307-2774 · solar@guardanthealth.com
All healthy volunteers studies in Arizona →
Shield Post-Approval Study Protocol (NCT06880055) | Bored Studies