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Shield Post-Approval Study Protocol
NCT06880055 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DIAGNOSTIC_TEST Shield Blood Test for colo-rectal cancer Screening
Study Locations (20)
Illinois
- Digestive Disease Consultants — Bourbonnais
- Digestive Disease Consultants — Bourbonnais
- Christie Clinic — Champaign
- Christie Clinic — Champaign
- GI Solutions of Illinois — Chicago
- GI Solutions of Illinois — Chicago
- Digestive Health Services — Downers Grove
- Digestive Health Services — Downers Grove
- Gastroenterology and Internal Medicine Specialists (GAIMS) — Lake Barrington
- Gastroenterology and Internal Medicine Specialists (GAIMS) — Lake Barrington
California
- Alliance Research Institute, LLC — Canoga Park
- Paragon Rx Clinical, Inc. — Garden Grove
- Amicis Research Center — Granada Hills
- Desert Oasis Healthcare Medical Group — Palm Springs
Arizona
- Southeast Valley Gastroenterology Consultants — Chandler
- Southeast Valley Gastroenterology Consultants — Gilbert
Connecticut
- Digestive Disease Associates — Branford
- Digestive Disease Associates — Branford
Florida
- Gastroenterology Consultants of Boca Raton, LLC — Boca Raton
- Physicians Group of South Florida — North Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,375 participants |
| Start Date | 2025-07-14 |
| Est. Completion | 2030-12-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06880055
The ClinicalTrials.gov registry entry for NCT06880055 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,375 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Guardant Health, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Colo-rectal Cancer appearing as the primary indexed condition, and to 1 intervention — of which Shield Blood Test for colo-rectal cancer Screening is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06880055 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Illinois, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06880055 about?
NCT06880055 is a clinical study titled "Shield Post-Approval Study Protocol". 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 usi...
What is the current status of trial NCT06880055?
This trial is currently recruiting. The enrollment target is 3,375 participants. The study started on 2025-07-14. Estimated completion is 2030-12-01.
What conditions does trial NCT06880055 study?
This clinical trial studies the following conditions: Colo-rectal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06880055?
The interventions under investigation include: Shield Blood Test for colo-rectal cancer Screening (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06880055?
This trial is sponsored by Guardant Health, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06880055 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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