AzTrials
AzTrials

Colo-rectal CancerSOLARNCT06880055

Shield Post-Approval Study Protocol

An observational study of Colo-rectal Cancer, run by Guardant Health, Inc. at 69 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 45 to 81 yearsHealthy volunteers can take part
Conditions the study is for
Colo-rectal Cancer
What is being tested?
Shield Blood Test for colo-rectal cancer Screening
How many people
3,375 participants
Where
69 sitesUnited States
Study dates
14 Jul 2025to 1 Dec 2030
Phase
Observational
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 81 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

69 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hannah Oakley contact

415-307-2774

solar@guardanthealth.com

69 sites in 1 country

United States69 sites, 58 recruiting

  • US Digestive Health at Blair

    Altoona, Pennsylvania, 16602

    Amanda Bianconi, 814-946-5469 ext. 3102, abianconi@usdhealth.com

    Mitul Patel

    Recruiting

  • Elite Primary Physicians, Inc.

    Anaheim, California, 92805

    Brandon Bonilla, 818-924-4708, b.bonilla@amicisresearch.com

    Ishminder Singh, MD

    Recruiting

  • Premier Family Physicians

    Austin, Texas, 78735

    Active, not recruiting

  • Premier Family Physicians

    Austin, Texas, 78746

    Active, not recruiting

  • Embassy Research Network

    Bloomfield Township, Michigan, 48302

    Zander Minano, 248-622-4083, zminano@embassyresearch.com

    Priyesh Patel, MD

    Recruiting

  • Gastroenterology Consultants of Boca Raton, LLC

    Boca Raton, Florida, 33486

    Lillian Urrutia, 561-453-3215, Lurrutia@yanuvia.com

    Todd Eisner

    Recruiting

  • Digestive Disease Consultants

    Bourbonnais, Illinois, 60914

    Hussain Boxwalla, 708-860-7866, hboxwalla@avicennaclinical.com

    Ashish Shah

    Recruiting

  • Digestive Disease Consultants

    Bourbonnais, Illinois, 60914

    Hussain Boxwalla, (708) 860-7866, hboxwalla@avicennaclinical.com

    Ashish Shah, MD

    Recruiting

  • Digestive Disease Associates

    Branford, Connecticut, 06405

    Lillian Urrutia, 561-453-3215, Lurrutia@yanuvia.com

    Daniel Zanchetti

    Recruiting

  • Digestive Disease Associates

    Branford, Connecticut, 06405

    Alan Bernegger, 920-472-1093, abernegger@yanuvia.com

    Daniel Zanchetti, MD

    Recruiting

  • Associated Gastroenterologists of Central New York

    Camillus, New York, 13031

    Alan Bernegger, 920-472-1093, abernegger@yanuvia.com

    John Sun

    Recruiting

  • Alliance Research Institute, LLC

    Canoga Park, California, 91304

    Victor Odogwu, 818-835-9085, vodogwu@allianceri.org

    Cameron Sikavi

    Recruiting

  • Cary Gastroenterology Associates

    Cary, North Carolina, 27518

    Alan Bernegger, 920-472-1093, abernegger@yanuvia.com

    Michael Brody

    Recruiting

  • Christie Clinic

    Champaign, Illinois, 61822

    Andrew Bartlett, 217-366-1331, abartlett@christieclinic.com

    Recruiting

  • Christie Clinic

    Champaign, Illinois, 61822

    Active, not recruiting

  • Southeast Valley Gastroenterology Consultants

    Chandler, Arizona, 85224

    Charles Schron, 480-899-2994, cmsphoenix@aol.com

    Charles Schron

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

    Shilpa Karanjit, 919-843-8519, shilpa_karanjit@med.unc.edu

    Sarah McGill, MD

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Shilpa Karanjit, 919-843-8519, shilpa_karanjit@med.unc.edu

    Sarah McGill, MD

    Recruiting

  • GI Solutions of Illinois

    Chicago, Illinois, 60631

    Hussain Boxwalla, 708-860-7866, hboxwalla@avicennaclinical.com

    Charles Berkelhammer

    Recruiting

  • GI Solutions of Illinois

    Chicago, Illinois, 60631

    Hussain Boxwalla, (708) 860-7866, hboxwalla@avicennaclinical.com

    Charles Berkelhammer, MD

    Recruiting

  • Gastroenterology Associates of New Jersey, LLC

    Clifton, New Jersey, 07013

    Alan Bernegger, 920-472-1093, abernegger@yanuvia.com

    Steven Gronowitz

    Recruiting

  • Northlake Gastroenterology Associates

    Covington, Louisiana, 70433

    Alan Bernegger, 920-472-1093, abernegger@yanuvia.com

    Gregory Mula

    Recruiting

  • Manuel Espinel MD PA

    Delray Beach, Florida, 33484

    Kristell Vazquez, 561-501-4646, kristell.vazquez92@gmail.com

    Manuel Espinel, MD

    Recruiting

  • Innova Pharma Research, LLC

    Doral, Florida, 33172

    Mario Llobet, 305-200-5646, mllobet@innovapresearch.com

    Giralt Yanez, MD

    Recruiting

  • Digestive Health Services

    Downers Grove, Illinois, 60515

    Hussain Boxwalla, 708-860-7866, hboxwalla@avicennaclinical.com

    Charles Berkelhammer

    Recruiting

  • Digestive Health Services

    Downers Grove, Illinois, 60515

    Hussain Boxwalla, (708) 860-7866, hboxwalla@avicennaclinical.com

    Charles Berkelhammer, MD

    Recruiting

  • Syracuse Gastroenterological Associates, P.C.

    East Syracuse, New York, 13057

    Alan Bernegger, 920-472-1093, abernegger@yanuvia.com

    Dennis Reedy

    Recruiting

  • Associated Gastroenterologists of Central New York

    Fayetteville, New York, 13066

    Alan Bernegger, 920-472-1093, abernegger@yanuvia.com

    John Sun

    Recruiting

  • Paragon Rx Clinical, Inc.

    Garden Grove, California, 92840

    Withdrawn

  • Southeast Valley Gastroenterology Consultants

    Gilbert, Arizona, 85297

    Charles Schron, 480-899-2994, cmsphoenix@aol.com

    Charles Schron

    Recruiting

  • Amicis Research Center

    Granada Hills, California, 91344

    Tyrone Rosales, 818-924-4708, tyrone.rosales@amicisresearch.com

    Pascal Dabel

    Recruiting

  • Gastroenterology Associates of New Jersey

    Hackensack, New Jersey, 07601

    Active, not recruiting

  • Northlake Gastroenterology Associates

    Hammond, Louisiana, 70403

    Alan Bernegger, 920-472-1093, abernegger@yanuvia.com

    Gregory Mula

    Recruiting

  • University of North Carolina at Chapel Hill

    Hillsborough, North Carolina, 27278

    Shilpa Karanjit, 919-843-8519, shilpa_karanjit@med.unc.edu

    Sarah McGill, MD

    Recruiting

  • Integrity Advanced Therapeutics, PLLC

    Houston, Texas, 77090

    Scott Ward, 281-453-2005, scott.ward@iat.care

    Howard Hamat

    Recruiting

  • Hutchinson Clinic

    Hutchinson, Kansas, 67502

    Active, not recruiting

  • Gastroenterology and Internal Medicine Specialists (GAIMS)

    Lake Barrington, Illinois, 60010

    Hussain Boxwalla, 708-860-7866, hboxwalla@avicennaclinical.com

    Nicole Gentile

    Recruiting

  • Gastroenterology and Internal Medicine Specialists (GAIMS)

    Lake Barrington, Illinois, 60010

    Hussain Boxwalla, (708) 860-7866, hboxwalla@avicennaclinical.com

    Nicole Gentile, MD

    Recruiting

  • Northshore Center for Gastroenterology (NCG)

    Libertyville, Illinois, 60048

    Hussain Boxwalla, (708) 860-7866, hboxwalla@avicennaclinical.com

    Nicole Gentile, MD

    Recruiting

  • Marisela Gonzalez, MD

    Miami, Florida, 33134

    Milagros Fernandez, 305-220-3700, mfernandez@mariselagonzalezmdpa.net

    Marisela Gonzalez, MD

    Recruiting

  • Research Associates of South Florida, LLC

    Miami, Florida, 33134

    Stephany Moreno, 786-476-8790, smoreno@researchassociatesfl.com

    Christian Andrade, MD

    Recruiting

  • Florida South Research Phase I-IV, Inc.

    Miami, Florida, 33166

    Lisbelle Revoredo, 305-418-0847, Lrevoredo@southfloridatrials.com

    Eduardo Viera, MD

    Recruiting

  • Piedmont Healthcare, P.A.

    Mocksville, North Carolina, 27028

    Active, not recruiting

  • Gastroenterology Associates of New Jersey, LLC

    Montclair, New Jersey, 07042

    Alan Bernegger, 920-472-1093, abernegger@yanuvia.com

    Steven Gronowitz

    Recruiting

  • NYU Langone

    New York, New York, 10010

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

    Peter Liang, MD

    Recruiting

  • Physicians Group of South Florida

    North Miami, Florida, 33181

    Daniel Wolfson, 305-609-1349, danielwolfson1126@yahoo.com

    Daniel Wolfson

    Recruiting

  • Southwest Gastroenterology (SWG)

    Oak Lawn, Illinois, 60453

    Hussain Boxwalla, 708-860-7866, hboxwalla@avicennaclinical.com

    Charles Berkelhammer

    Recruiting

  • Southwest Gastroenterology (SWG)

    Oak Lawn, Illinois, 60453

    Hussain Boxwalla Chief Operating Officer/Owner, (708) 860-7866, hboxwalla@avicennaclinical.com

    Charles Berkelhammer, MD

    Recruiting

  • Orchard Park Family Practice

    Orchard Park, New York, 14127

    Elizabeth Swanson, 716-339-3666, swanson@circuitclinical.com

    Richard Ruh

    Recruiting

  • Desert Oasis Healthcare Medical Group

    Palm Springs, California, 92262

    Brooke Yates, 760-320-9505, byates@mydohc.com

    Michael F Jardula

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Alexis Winters, 215-349-8222, alexis.winters@pennmedicine.upenn.edu

    Bryson Katona, MD

    Recruiting

  • Pinehurst Medical Clinic

    Pinehurst, North Carolina, 28374

    Withdrawn

  • Health Living at Pottstown Medical Specialists, Inc

    Pottstown, Pennsylvania, 19464

    Stacy Cowden, 610-858-9174, scowden@circuitclinical.com

    Wade Brosius

    Recruiting

  • Quinn Healthcare, PLLC

    Ridgeland, Mississippi, 39157

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

    Timothy Quinn, MD

    Recruiting

  • Gastroenterology Associates of New Jersey, LLC

    Ridgewood, New Jersey, 07450

    Alan Bernegger, 920-472-1093, abernegger@yanuvia.com

    Steven Gronowitz

    Recruiting

  • Sanford Cardiology Pinehurst Medical Clinic

    Sanford, North Carolina, 27330

    Withdrawn

  • Center for Digestive Disease

    Shenandoah, Texas, 77384

    Melissa Clark, 936-321-5440, melissa.clark@cddgastro.net

    Shail Maheshwari

    Recruiting

  • Amicis Research Center

    Sherman Oaks, California, 91403

    William Calder, 818-464-4870, w.calder@amicisresearch.com

    Ali Sheybani, MD

    Recruiting

  • Piedmont Healthcare LLC

    Statesville, North Carolina, 28625

    Active, not recruiting

  • NMC Research

    Tampa, Florida, 33607

    Jose Martinez, 813-374-0568, jmartinez@nmc-research.com

    Osvanny Nodal, MD

    Recruiting

  • Horizon Clinical Research Group

    Tomball, Texas, 77375

    Shatabdi Satpathi, 281-803-9960, shatabdi@horizoncrg.com

    Amar Dodda

    Recruiting

  • Horizon Clinical Research Group

    Tomball, Texas, 77375

    Shatabdi Satpathi, 281-803-9960, shatabdi@horizoncrg.com

    Amar Dodda, MD

    Recruiting

  • Amicis Research Center

    Valencia, California, 91355

    Veronica Macias, 818-639-8822, veronica.macias@amicisresearch.com

    Dennis Lewis, MD

    Recruiting

  • GastroCare LI

    Valley Stream, New York, 11581

    Alan Bernegger, 920-472-1093, abernegger@yanuvia.com

    Brandon Rieders

    Recruiting

  • GastroCare LI

    Valley Stream, New York, 11581

    Alan Bernegger, 920-472-1093, abernegger@yanuvia.com

    Brandon Rieders, MD

    Recruiting

  • Gastroenterology Associates of New Jersey, LLC

    Wayne, New Jersey, 07470

    Alan Bernegger, 920-472-1093, abernegger@yanuvia.com

    Steven Gronowitz

    Recruiting

  • Gastroenterology Associates of New Jersey

    Wayne, New Jersey, 07470

    Active, not recruiting

  • Tidewater Physician Multispecialty Group Clinical Research

    Williamsburg, Virginia, 23188

    Gabrielle Land, 757-707-3503, gabrielle.land@tpmgpc.com

    Frances Jones

    Recruiting

  • Coral Clinics

    Winnetka, California, 91306

    William Calder, 818-924-4708, w.calder@amicisresearch.com

    Amin Khorsandi, MD

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Colorectal cancer (CRC) is the fourth most diagnosed cancer and second leading cause of cancer-related death in the US, with an estimated 53,010 deaths attributable to CRC in 2024. The risk of CRC increases with age, with the majority of cases and deaths occurring in individuals aged 65 years or older. While the incidence of CRC in Americans 65 years of age or older has decreased over the last decade, the incidence of CRC in younger Americans aged 55 years or younger has been increasing since the mid-1990s. CRC disproportionately affects minority populations, with American Indian/Alaska Native and Black/African American populations having the highest incidence and mortality rates1; this is further exacerbated by systemic barriers to current CRC screening options.

CRC primarily arises from a precursor lesion, the adenomatous polyp (i.e., adenoma), that grows from the epithelial cells of the colorectal mucosa. Adenomas that grow larger than 10 mm or have elements indicating a risk of malignant transformation (e.g., high-grade dysplasia or villous features) are defined as advanced adenomas (AAs). The vast number of adenomas, even those with features classifying them as AAs, do not progress into a colorectal malignancy. Colonoscopy cannot always distinguish adenomas or advanced adenomas from other polyp histology; thus, polypectomy is routinely performed for lesions identified on endoscopy. The transition rate from adenoma onset to CRC development is estimated to be 12.5 to 25 years. This slow transition from adenoma onset to CRC onset allows for multiple CRC screening opportunities over a lifetime, providing the ability to intervene along the disease development course and the potential to detect and remove adenomas, prevent colorectal cancer, and reduce CRC incidence and subsequently, disease mortality.

Once CRC has developed, tumor staging is consistent with other solid tumors and defined based on how far the cancer has spread within the body. In Stage 0 (carcinoma in situ), the cancer cells are only in the colorectal mucosa. In Stage I, the cancer has spread to the muscular layer of the colorectum but not to nearby tissue or lymph nodes. In Stage II, the cancer has grown through the wall of the colorectum and potentially to nearby tissues but has not spread to nearby lymph nodes. In Stage III, the cancer has spread to nearby lymph nodes but not to distant parts of the body. In Stage IV, the cancer has spread to one or more distant parts of the body. The estimated time frame from CRC onset to a symptomatic diagnosis of CRC is estimated to be 4-5 years, in the absence of early detection through asymptomatic cancer screening. Tumor size and location can influence the rate of transition through the stages of CRC. The 5-year survival rate for localized disease (Stage I-II) is 91%, and is 72% for regional disease (Stage III), while the 5-year survival for metastatic disease (Stage IV) is only 14%. These statistics highlight the ability to reduce CRC-related mortality by detection of early-stage (Stage I-III) disease where therapeutic intervention has the potential to result in a cure.

Being tested
Shield Blood Test for colo-rectal cancer Screening
Keywords
Screening, Shield
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shield Blood Test for colo-rectal cancer ScreeningDiagnostic test

    Shield Blood Test for colo-rectal cancer Screening

Study groups in NCT06880055
Study groupRoleWhat they receive
Enrolled SubjectsSubjects age 45 to 81 at average risk of CRC who meet inclusion, do not meet exclusion criteria, and who successfully enroll in the study.
Receives: Diagnostic Test: Shield Blood Test for colo-rectal cancer Screening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance measures of the Shield test will be assessed for the second testing interval

    • Advanced Neoplasia Specificity
    • AA Sensitivity
    • CRC Sensitivity
    • PPV for: CRC, AA, and advanced neoplasia.
    • NPV for: CRC and advanced neoplasia

    Measured: 33-42 Months Post-Enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2025
  2. Study start14 Jul 2025
  3. Primary completion1 Sep 2030 (estimated)
  4. Study completion1 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,375 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06880055
Sponsor's protocol ID
07-GI-003
Acronym
SOLAR
Status last verified
Aug 2026
First submitted
11 Mar 2025
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Colo-rectal Cancer, run by Guardant Health, Inc. at 69 sites 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 18 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: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites 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?

Contact Hannah Oakley (415-307-2774, solar@guardanthealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance measures of the Shield test will be assessed for the second testing interval (time frame: 33-42 Months Post-Enrollment). 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 NCT06880055.

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 7 Aug 2026.

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