Shield Post-Approval Study Protocol (SOLAR)

March 18, 2026 updated by: Guardant Health, Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

3375

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Southeast Valley Gastroenterology Consultants
        • Contact:
        • Principal Investigator:
          • Charles Schron
      • Gilbert, Arizona, United States, 85297
        • Recruiting
        • Southeast Valley Gastroenterology Consultants
        • Contact:
        • Principal Investigator:
          • Charles Schron
    • California
      • Canoga Park, California, United States, 91304
        • Recruiting
        • Alliance Research Institute, LLC
        • Contact:
        • Principal Investigator:
          • Cameron Sikavi
      • Garden Grove, California, United States, 92840
        • Withdrawn
        • Paragon RX Clinical, Inc.
      • Granada Hills, California, United States, 91344
      • Palm Springs, California, United States, 92262
        • Recruiting
        • Desert Oasis Healthcare Medical Group
        • Principal Investigator:
          • Michael F Jardula
        • Contact:
    • Connecticut
      • Branford, Connecticut, United States, 06405
        • Recruiting
        • Digestive Disease Associates
        • Contact:
        • Principal Investigator:
          • Daniel Zanchetti, MD
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Gastroenterology Consultants of Boca Raton, LLC
        • Contact:
        • Principal Investigator:
          • Todd Eisner
      • North Miami, Florida, United States, 33181
        • Recruiting
        • Physicians Group of South Florida
        • Contact:
        • Principal Investigator:
          • Daniel Wolfson
    • Illinois
      • Bourbonnais, Illinois, United States, 60914
        • Recruiting
        • Digestive Disease Consultants
        • Principal Investigator:
          • Ashish Shah, MD
        • Contact:
      • Champaign, Illinois, United States, 61822
      • Champaign, Illinois, United States, 61822
        • Active, not recruiting
        • Christie Clinic
      • Chicago, Illinois, United States, 60631
        • Recruiting
        • GI Solutions of Illinois
        • Principal Investigator:
          • Charles Berkelhammer, MD
        • Contact:
      • Downers Grove, Illinois, United States, 60515
        • Recruiting
        • Digestive Health Services
        • Principal Investigator:
          • Charles Berkelhammer, MD
        • Contact:
      • Lake Barrington, Illinois, United States, 60010
        • Recruiting
        • Gastroenterology and Internal Medicine Specialists (GAIMS)
        • Contact:
        • Principal Investigator:
          • Nicole Gentile, MD
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • Northshore Center for Gastroenterology (NCG)
        • Contact:
        • Principal Investigator:
          • Nicole Gentile, MD
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • Southwest Gastroenterology (SWG)
        • Principal Investigator:
          • Charles Berkelhammer, MD
        • Contact:
    • Kansas
      • Hutchinson, Kansas, United States, 67502
        • Active, not recruiting
        • Hutchinson Clinic
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Northlake Gastroenterology Associates
        • Contact:
        • Principal Investigator:
          • Gregory Mula
      • Hammond, Louisiana, United States, 70403
        • Recruiting
        • Northlake Gastroenterology Associates
        • Contact:
        • Principal Investigator:
          • Gregory Mula
    • New Jersey
      • Clifton, New Jersey, United States, 07013
        • Recruiting
        • Gastroenterology Associates of New Jersey, LLC
        • Contact:
        • Principal Investigator:
          • Steven Gronowitz
      • Hackensack, New Jersey, United States, 07601
        • Active, not recruiting
        • Gastroenterology Associates Of New Jersey
      • Montclair, New Jersey, United States, 07042
        • Recruiting
        • Gastroenterology Associates of New Jersey, LLC
        • Contact:
        • Principal Investigator:
          • Steven Gronowitz
      • Ridgewood, New Jersey, United States, 07450
        • Recruiting
        • Gastroenterology Associates of New Jersey, LLC
        • Contact:
        • Principal Investigator:
          • Steven Gronowitz
      • Wayne, New Jersey, United States, 07470
        • Recruiting
        • Gastroenterology Associates of New Jersey, LLC
        • Contact:
        • Principal Investigator:
          • Steven Gronowitz
      • Wayne, New Jersey, United States, 07470
        • Active, not recruiting
        • Gastroenterology Associates Of New Jersey
    • New York
      • Camillus, New York, United States, 13031
        • Recruiting
        • Associated Gastroenterologists of Central New York
        • Principal Investigator:
          • John Sun
        • Contact:
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Syracuse Gastroenterological Associates, P.C.
        • Principal Investigator:
          • Dennis Reedy
        • Contact:
      • Fayetteville, New York, United States, 13066
        • Recruiting
        • Associated Gastroenterologists of Central New York
        • Principal Investigator:
          • John Sun
        • Contact:
      • Orchard Park, New York, United States, 14127
        • Recruiting
        • Orchard Park Family Practice
        • Contact:
        • Principal Investigator:
          • Richard Ruh
      • Valley Stream, New York, United States, 11581
        • Recruiting
        • GastroCare LI
        • Contact:
        • Principal Investigator:
          • Brandon Rieders, MD
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Recruiting
        • Cary Gastroenterology Associates
        • Principal Investigator:
          • Michael Brody
        • Contact:
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Principal Investigator:
          • Sarah McGill, MD
        • Contact:
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Principal Investigator:
          • Sarah McGill, MD
        • Contact:
      • Hillsborough, North Carolina, United States, 27278
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Principal Investigator:
          • Sarah McGill, MD
        • Contact:
      • Mocksville, North Carolina, United States, 27028
        • Active, not recruiting
        • Piedmont Healthcare, P.A.
      • Pinehurst, North Carolina, United States, 28374
        • Withdrawn
        • Pinehurst Medical Clinic
      • Sanford, North Carolina, United States, 27330
        • Withdrawn
        • Sanford Cardiology Pinehurst Medical Clinic
      • Statesville, North Carolina, United States, 28625
        • Active, not recruiting
        • Piedmont Healthcare LLC
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Recruiting
        • US Digestive Health at Blair
        • Principal Investigator:
          • Mitul Patel
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19104
      • Pottstown, Pennsylvania, United States, 19464
        • Recruiting
        • Health Living at Pottstown Medical Specialists, Inc
        • Contact:
        • Principal Investigator:
          • Wade Brosius
    • Texas
      • Austin, Texas, United States, 78735
        • Active, not recruiting
        • Premier Family Physicians
      • Austin, Texas, United States, 78746
        • Active, not recruiting
        • Premier Family Physicians
      • Houston, Texas, United States, 77090
        • Recruiting
        • Integrity Advanced Therapeutics, PLLC
        • Contact:
        • Principal Investigator:
          • Howard Hamat
      • Shenandoah, Texas, United States, 77384
        • Recruiting
        • Center for Digestive Disease
        • Principal Investigator:
          • Shail Maheshwari
        • Contact:
      • Tomball, Texas, United States, 77375
        • Recruiting
        • Horizon Clinical Research Group
        • Contact:
        • Principal Investigator:
          • Amar Dodda, MD
    • Virginia
      • Williamsburg, Virginia, United States, 23188
        • Recruiting
        • Tidewater Physician Multispecialty Group Clinical Research
        • Principal Investigator:
          • Frances Jones
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: Shield Blood Test for colo-rectal cancer Screening
Shield Blood Test for colo-rectal cancer Screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance measures of the Shield test will be assessed for the second testing interval
Time Frame: 33-42 Months Post-Enrollment
  • Advanced Neoplasia Specificity
  • AA Sensitivity
  • CRC Sensitivity
  • PPV for: CRC, AA, and advanced neoplasia.
  • NPV for: CRC and advanced neoplasia
33-42 Months Post-Enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guardant Health, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2025

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 17, 2025

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-GI-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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