Recruiting

Shield

Sponsor:

Guardant Health, Inc.

Code:

NCT06880055

Conditions

Colo-rectal Cancer

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Shield Blood Test for colo-rectal cancer Screening

Study Details

Brief summary:

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.

Conditions

Colo-rectal Cancer

Study ID

NCT06880055

Start date

Jul 14, 2025

Status verified date

Aug, 2026

Completion date

Dec 1, 2030

Anticipated

Primary completion date

Sep 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

3375 participants

Anticipated

Interventions and Outcome Measures

Arms

Enrolled Subjects

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.

Interventions

Shield Blood Test for colo-rectal cancer Screening

Shield Blood Test for colo-rectal cancer Screening

Primary outcome measure

  • Performance measures of the Shield test will be assessed for the second testing interval [ Time Frame: 33-42 Months Post-Enrollment ]

Central Contacts and Locations

Central contacts

Hannah Oakley

415-307-2774solar@guardanthealth.com

Locations

Southeast Valley Gastroenterology Consultants

Recruiting

Chandler, Arizona, United States, 85224

Contacts

Charles Schron

480-899-2994cmsphoenix@aol.com

Principal Investigator:

Charles Schron

Southeast Valley Gastroenterology Consultants

Recruiting

Gilbert, Arizona, United States, 85297

Contacts

Charles Schron

480-899-2994cmsphoenix@aol.com

Principal Investigator:

Charles Schron

Elite Primary Physicians, Inc.

Recruiting

Anaheim, California, United States, 92805

Contacts

Brandon Bonilla

818-924-4708b.bonilla@amicisresearch.com

Principal Investigator:

Ishminder Singh, MD

Alliance Research Institute, LLC

Recruiting

Canoga Park, California, United States, 91304

Contacts

Victor Odogwu

818-835-9085vodogwu@allianceri.org

Principal Investigator:

Cameron Sikavi

Amicis Research Center

Recruiting

Granada Hills, California, United States, 91344

Contacts

Tyrone Rosales

818-924-4708tyrone.rosales@amicisresearch.com

Principal Investigator:

Pascal Dabel

Desert Oasis Healthcare Medical Group

Recruiting

Palm Springs, California, United States, 92262

Contacts

Brooke Yates

760-320-9505byates@mydohc.com

Principal Investigator:

Michael F Jardula

Amicis Research Center

Recruiting

Sherman Oaks, California, United States, 91403

Contacts

William Calder

818-464-4870w.calder@amicisresearch.com

Principal Investigator:

Ali Sheybani, MD

Amicis Research Center

Recruiting

Valencia, California, United States, 91355

Contacts

Veronica Macias

818-639-8822veronica.macias@amicisresearch.com

Principal Investigator:

Dennis Lewis, MD

Coral Clinics

Recruiting

Winnetka, California, United States, 91306

Contacts

William Calder

818-924-4708w.calder@amicisresearch.com

Principal Investigator:

Amin Khorsandi, MD

Digestive Disease Associates

Recruiting

Branford, Connecticut, United States, 06405

Contacts

Lillian Urrutia

561-453-3215Lurrutia@yanuvia.com

Principal Investigator:

Daniel Zanchetti

Digestive Disease Associates

Recruiting

Branford, Connecticut, United States, 06405

Contacts

Alan Bernegger

920-472-1093abernegger@yanuvia.com

Principal Investigator:

Daniel Zanchetti, MD

Gastroenterology Consultants of Boca Raton, LLC

Recruiting

Boca Raton, Florida, United States, 33486

Contacts

Lillian Urrutia

561-453-3215Lurrutia@yanuvia.com

Principal Investigator:

Todd Eisner

Manuel Espinel MD PA

Recruiting

Delray Beach, Florida, United States, 33484

Contacts

Kristell Vazquez

561-501-4646kristell.vazquez92@gmail.com

Principal Investigator:

Manuel Espinel, MD

Innova Pharma Research, LLC

Recruiting

Doral, Florida, United States, 33172

Contacts

Mario Llobet

305-200-5646mllobet@innovapresearch.com

Principal Investigator:

Giralt Yanez, MD

Marisela Gonzalez, MD

Recruiting

Miami, Florida, United States, 33134

Contacts

Milagros Fernandez

305-220-3700mfernandez@mariselagonzalezmdpa.net

Principal Investigator:

Marisela Gonzalez, MD

Research Associates of South Florida, LLC

Recruiting

Miami, Florida, United States, 33134

Contacts

Stephany Moreno

786-476-8790smoreno@researchassociatesfl.com

Principal Investigator:

Christian Andrade, MD

Florida South Research Phase I-IV, Inc.

Recruiting

Miami, Florida, United States, 33166

Contacts

Lisbelle Revoredo

305-418-0847Lrevoredo@southfloridatrials.com

Principal Investigator:

Eduardo Viera, MD

Physicians Group of South Florida

Recruiting

North Miami, Florida, United States, 33181

Contacts

Daniel Wolfson

305-609-1349danielwolfson1126@yahoo.com

Principal Investigator:

Daniel Wolfson

NMC Research

Recruiting

Tampa, Florida, United States, 33607

Contacts

Jose Martinez

813-374-0568jmartinez@nmc-research.com

Principal Investigator:

Osvanny Nodal, MD

Digestive Disease Consultants

Recruiting

Bourbonnais, Illinois, United States, 60914

Contacts

Hussain Boxwalla

708-860-7866hboxwalla@avicennaclinical.com

Principal Investigator:

Ashish Shah

Digestive Disease Consultants

Recruiting

Bourbonnais, Illinois, United States, 60914

Contacts

Hussain Boxwalla

(708) 860-7866hboxwalla@avicennaclinical.com

Principal Investigator:

Ashish Shah, MD

Christie Clinic

Recruiting

Champaign, Illinois, United States, 61822

Contacts

Andrew Bartlett

217-366-1331abartlett@christieclinic.com

GI Solutions of Illinois

Recruiting

Chicago, Illinois, United States, 60631

Contacts

Hussain Boxwalla

708-860-7866hboxwalla@avicennaclinical.com

Principal Investigator:

Charles Berkelhammer

GI Solutions of Illinois

Recruiting

Chicago, Illinois, United States, 60631

Contacts

Hussain Boxwalla

(708) 860-7866hboxwalla@avicennaclinical.com

Principal Investigator:

Charles Berkelhammer, MD

Digestive Health Services

Recruiting

Downers Grove, Illinois, United States, 60515

Contacts

Hussain Boxwalla

708-860-7866hboxwalla@avicennaclinical.com

Principal Investigator:

Charles Berkelhammer

Digestive Health Services

Recruiting

Downers Grove, Illinois, United States, 60515

Contacts

Hussain Boxwalla

(708) 860-7866hboxwalla@avicennaclinical.com

Principal Investigator:

Charles Berkelhammer, MD

Gastroenterology and Internal Medicine Specialists (GAIMS)

Recruiting

Lake Barrington, Illinois, United States, 60010

Contacts

Hussain Boxwalla

708-860-7866hboxwalla@avicennaclinical.com

Principal Investigator:

Nicole Gentile

Gastroenterology and Internal Medicine Specialists (GAIMS)

Recruiting

Lake Barrington, Illinois, United States, 60010

Contacts

Hussain Boxwalla

(708) 860-7866hboxwalla@avicennaclinical.com

Principal Investigator:

Nicole Gentile, MD

Northshore Center for Gastroenterology (NCG)

Recruiting

Libertyville, Illinois, United States, 60048

Contacts

Hussain Boxwalla

(708) 860-7866hboxwalla@avicennaclinical.com

Principal Investigator:

Nicole Gentile, MD

Southwest Gastroenterology (SWG)

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Hussain Boxwalla

708-860-7866hboxwalla@avicennaclinical.com

Principal Investigator:

Charles Berkelhammer

Southwest Gastroenterology (SWG)

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Hussain Boxwalla Chief Operating Officer/Owner

(708) 860-7866hboxwalla@avicennaclinical.com

Principal Investigator:

Charles Berkelhammer, MD

Northlake Gastroenterology Associates

Recruiting

Covington, Louisiana, United States, 70433

Contacts

Alan Bernegger

920-472-1093abernegger@yanuvia.com

Principal Investigator:

Gregory Mula

Northlake Gastroenterology Associates

Recruiting

Hammond, Louisiana, United States, 70403

Contacts

Alan Bernegger

920-472-1093abernegger@yanuvia.com

Principal Investigator:

Gregory Mula

Embassy Research Network

Recruiting

Bloomfield Township, Michigan, United States, 48302

Contacts

Zander Minano

248-622-4083zminano@embassyresearch.com

Principal Investigator:

Priyesh Patel, MD

Quinn Healthcare, PLLC

Recruiting

Ridgeland, Mississippi, United States, 39157

Contacts

Khadijra Lockwood

601-487-6482Khadijra.lockwood@roviaclinical.com

Principal Investigator:

Timothy Quinn, MD

Gastroenterology Associates of New Jersey, LLC

Recruiting

Clifton, New Jersey, United States, 07013

Contacts

Alan Bernegger

920-472-1093abernegger@yanuvia.com

Principal Investigator:

Steven Gronowitz

Gastroenterology Associates of New Jersey, LLC

Recruiting

Montclair, New Jersey, United States, 07042

Contacts

Alan Bernegger

920-472-1093abernegger@yanuvia.com

Principal Investigator:

Steven Gronowitz

Gastroenterology Associates of New Jersey, LLC

Recruiting

Ridgewood, New Jersey, United States, 07450

Contacts

Alan Bernegger

920-472-1093abernegger@yanuvia.com

Principal Investigator:

Steven Gronowitz

Gastroenterology Associates of New Jersey, LLC

Recruiting

Wayne, New Jersey, United States, 07470

Contacts

Alan Bernegger

920-472-1093abernegger@yanuvia.com

Principal Investigator:

Steven Gronowitz

Associated Gastroenterologists of Central New York

Recruiting

Camillus, New York, United States, 13031

Contacts

Alan Bernegger

920-472-1093abernegger@yanuvia.com

Principal Investigator:

John Sun

Syracuse Gastroenterological Associates, P.C.

Recruiting

East Syracuse, New York, United States, 13057

Contacts

Alan Bernegger

920-472-1093abernegger@yanuvia.com

Principal Investigator:

Dennis Reedy

Associated Gastroenterologists of Central New York

Recruiting

Fayetteville, New York, United States, 13066

Contacts

Alan Bernegger

920-472-1093abernegger@yanuvia.com

Principal Investigator:

John Sun

NYU Langone

Recruiting

New York, New York, United States, 10010

Contacts

Anika Zaman

(212) 686-7500 ext 15745anika.zaman@nyulangone.org

Principal Investigator:

Peter Liang, MD

Orchard Park Family Practice

Recruiting

Orchard Park, New York, United States, 14127

Contacts

Elizabeth Swanson

716-339-3666swanson@circuitclinical.com

Principal Investigator:

Richard Ruh

GastroCare LI

Recruiting

Valley Stream, New York, United States, 11581

Contacts

Alan Bernegger

920-472-1093abernegger@yanuvia.com

Principal Investigator:

Brandon Rieders

GastroCare LI

Recruiting

Valley Stream, New York, United States, 11581

Contacts

Alan Bernegger

920-472-1093abernegger@yanuvia.com

Principal Investigator:

Brandon Rieders, MD

Cary Gastroenterology Associates

Recruiting

Cary, North Carolina, United States, 27518

Contacts

Alan Bernegger

920-472-1093abernegger@yanuvia.com

Principal Investigator:

Michael Brody

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Shilpa Karanjit

919-843-8519shilpa_karanjit@med.unc.edu

Principal Investigator:

Sarah McGill, MD

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Shilpa Karanjit

919-843-8519shilpa_karanjit@med.unc.edu

Principal Investigator:

Sarah McGill, MD

University of North Carolina at Chapel Hill

Recruiting

Hillsborough, North Carolina, United States, 27278

Contacts

Shilpa Karanjit

919-843-8519shilpa_karanjit@med.unc.edu

Principal Investigator:

Sarah McGill, MD

US Digestive Health at Blair

Recruiting

Altoona, Pennsylvania, United States, 16602

Contacts

Amanda Bianconi

814-946-5469abianconi@usdhealth.com

Principal Investigator:

Mitul Patel

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Alexis Winters

215-349-8222alexis.winters@pennmedicine.upenn.edu

Principal Investigator:

Bryson Katona, MD

Health Living at Pottstown Medical Specialists, Inc

Recruiting

Pottstown, Pennsylvania, United States, 19464

Contacts

Stacy Cowden

610-858-9174scowden@circuitclinical.com

Principal Investigator:

Wade Brosius

Integrity Advanced Therapeutics, PLLC

Recruiting

Houston, Texas, United States, 77090

Contacts

Scott Ward

281-453-2005scott.ward@iat.care

Principal Investigator:

Howard Hamat

Center for Digestive Disease

Recruiting

Shenandoah, Texas, United States, 77384

Contacts

Melissa Clark

936-321-5440melissa.clark@cddgastro.net

Principal Investigator:

Shail Maheshwari

Horizon Clinical Research Group

Recruiting

Tomball, Texas, United States, 77375

Contacts

Shatabdi Satpathi

281-803-9960shatabdi@horizoncrg.com

Principal Investigator:

Amar Dodda

Horizon Clinical Research Group

Recruiting

Tomball, Texas, United States, 77375

Contacts

Shatabdi Satpathi

281-803-9960shatabdi@horizoncrg.com

Principal Investigator:

Amar Dodda, MD

Tidewater Physician Multispecialty Group Clinical Research

Recruiting

Williamsburg, Virginia, United States, 23188

Contacts

Gabrielle Land

757-707-3503gabrielle.land@tpmgpc.com

Principal Investigator:

Frances Jones

More Information

Sponsor

Guardant Health, Inc.

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • Screening
  • Shield

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Guardant Health, Inc. on 2026-08-07.