NCT06880055ClinicalTrials.gov

Shield Post-Approval Study Protocol

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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…

Beobachtend3.375 Teilnehmende gesucht69 Studienzentren1 Land

Kategorien

Onkologie60%Gastroenterologie und Hepatologie40%

In 1 Register registriert

ClinicalTrials.govNCT06880055Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert letzten Monat

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2025-03-17; recorded start 2025-07-14
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
Not stated: Whether the study is blinded is not stated in the registry recordNo masking information is recorded
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 5 other studies in this databaseCounted from the lead sponsor named in the record (Guardant Health, Inc.)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Masking not stated in the record
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 56 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study: 3,375 participants (target), run at 69 sites.

How this score is built

Enrolment35/40
3,375 participants (target)
Site count20/25
56 sites
Country count0/15
Single country
Planned duration10/10
Planned over about 66 months
Sponsor scale2/10
Guardant Health, Inc. has led 6 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Zusammenfassung

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.

Erkrankungen

Colo-rectal Cancer

Eignung

Eignung
Geschlecht	Alle
Alter	45 Years – 81 Years
Gesunde Freiwillige	Ja
Stichprobenverfahren	PROBABILITY_SAMPLE

Studienpopulation

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

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Beobachtend
Phase	Im Registereintrag nicht angegeben
Zuteilung	Im Registereintrag nicht angegeben
Interventionsmodell	Im Registereintrag nicht angegeben
Primäres Ziel	Im Registereintrag nicht angegeben
Verblindung	Im Registereintrag nicht angegeben
Teilnahme	3.375 Teilnehmende gesucht

Sponsor und Mitwirkende

Guardant Health, Inc. Sponsor

Studienarme und Interventionen

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.

Interventionen

Diagnostischer Test Shield Blood Test for colo-rectal cancer Screening
Shield Blood Test for colo-rectal cancer Screening

Endpunkte

Primärer Endpunkt
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
Zeitrahmen 33-42 Months Post-Enrollment

Daten

Daten
Startdatum	14. Juli 2025 (tatsächlich)
Primärer Abschluss	1. September 2030 (geschätzt)
Abschluss	1. Dezember 2030 (geschätzt)
Erstveröffentlichung	17. März 2025 (tatsächlich)
Zuletzt aktualisiert	7. August 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	August 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

58 Studienzentren rekrutieren

United States

United States
Einrichtung	Stadt	Bundesland oder Region	Status
US Digestive Health at Blair	Altoona	Pennsylvania	Rekrutiert
Elite Primary Physicians, Inc.	Anaheim	California	Rekrutiert
Premier Family Physicians	Austin	Texas	Aktiv, rekrutiert nicht
Premier Family Physicians	Austin	Texas	Aktiv, rekrutiert nicht
Embassy Research Network	Bloomfield Township	Michigan	Rekrutiert
Gastroenterology Consultants of Boca Raton, LLC	Boca Raton	Florida	Rekrutiert
Digestive Disease Consultants	Bourbonnais	Illinois	Rekrutiert
Digestive Disease Consultants	Bourbonnais	Illinois	Rekrutiert
Digestive Disease Associates	Branford	Connecticut	Rekrutiert
Digestive Disease Associates	Branford	Connecticut	Rekrutiert
Associated Gastroenterologists of Central New York	Camillus	New York	Rekrutiert
Alliance Research Institute, LLC	Canoga Park	California	Rekrutiert
Cary Gastroenterology Associates	Cary	North Carolina	Rekrutiert
Christie Clinic	Champaign	Illinois	Aktiv, rekrutiert nicht
Christie Clinic	Champaign	Illinois	Rekrutiert
Southeast Valley Gastroenterology Consultants	Chandler	Arizona	Rekrutiert
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	Rekrutiert
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	Rekrutiert
GI Solutions of Illinois	Chicago	Illinois	Rekrutiert
GI Solutions of Illinois	Chicago	Illinois	Rekrutiert
Gastroenterology Associates of New Jersey, LLC	Clifton	New Jersey	Rekrutiert
Northlake Gastroenterology Associates	Covington	Louisiana	Rekrutiert
Manuel Espinel MD PA	Delray Beach	Florida	Rekrutiert
Innova Pharma Research, LLC	Doral	Florida	Rekrutiert
Digestive Health Services	Downers Grove	Illinois	Rekrutiert
Digestive Health Services	Downers Grove	Illinois	Rekrutiert
Syracuse Gastroenterological Associates, P.C.	East Syracuse	New York	Rekrutiert
Associated Gastroenterologists of Central New York	Fayetteville	New York	Rekrutiert
Paragon Rx Clinical, Inc.	Garden Grove	California	Zurückgezogen
Southeast Valley Gastroenterology Consultants	Gilbert	Arizona	Rekrutiert
Amicis Research Center	Granada Hills	California	Rekrutiert
Gastroenterology Associates of New Jersey	Hackensack	New Jersey	Aktiv, rekrutiert nicht
Northlake Gastroenterology Associates	Hammond	Louisiana	Rekrutiert
University of North Carolina at Chapel Hill	Hillsborough	North Carolina	Rekrutiert
Integrity Advanced Therapeutics, PLLC	Houston	Texas	Rekrutiert
Hutchinson Clinic	Hutchinson	Kansas	Aktiv, rekrutiert nicht
Gastroenterology and Internal Medicine Specialists (GAIMS)	Lake Barrington	Illinois	Rekrutiert
Gastroenterology and Internal Medicine Specialists (GAIMS)	Lake Barrington	Illinois	Rekrutiert
Northshore Center for Gastroenterology (NCG)	Libertyville	Illinois	Rekrutiert
Research Associates of South Florida, LLC	Miami	Florida	Rekrutiert
Marisela Gonzalez, MD	Miami	Florida	Rekrutiert
Florida South Research Phase I-IV, Inc.	Miami	Florida	Rekrutiert
Piedmont Healthcare, P.A.	Mocksville	North Carolina	Aktiv, rekrutiert nicht
Gastroenterology Associates of New Jersey, LLC	Montclair	New Jersey	Rekrutiert
NYU Langone	New York	New York	Rekrutiert
Physicians Group of South Florida	North Miami	Florida	Rekrutiert
Southwest Gastroenterology (SWG)	Oak Lawn	Illinois	Rekrutiert
Southwest Gastroenterology (SWG)	Oak Lawn	Illinois	Rekrutiert
Orchard Park Family Practice	Orchard Park	New York	Rekrutiert
Desert Oasis Healthcare Medical Group	Palm Springs	California	Rekrutiert

19 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

7. August 2026
Studienzentrum hinzugefügt
13 sites added (69 total)
5669

https://xmedica.io/trials/ctgov/NCT06880055