NCT06880055ClinicalTrials.gov

Shield Post-Approval Study Protocol

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.

יצירת קשר עם המחקר

בקצרה

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…

תצפיתידרושים 3,375 משתתפים69 אתריםמדינה אחת

קטגוריות

אונקולוגיה60%גסטרואנטרולוגיה והפטולוגיה40%

רשום במרשם אחד

ClinicalTrials.govNCT06880055פתיחת רשומה זו ב־ClinicalTrials.govסונכרן החודש שעבר

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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.

מצבים רפואיים

Colo-rectal Cancer

זכאות

זכאות
מין	הכול
גילאים	45 Years – 81 Years
מתנדבים בריאים	כן
שיטת דגימה	PROBABILITY_SAMPLE

אוכלוסיית המחקר

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

זכאות כפי שנכתבה במרשם

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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקר	תצפיתי
שלב	לא צוין ברשומת המרשם
הקצאה	לא צוין ברשומת המרשם
מודל ההתערבות	לא צוין ברשומת המרשם
מטרה ראשית	לא צוין ברשומת המרשם
הסתרה	לא צוין ברשומת המרשם
גיוס	דרושים 3,375 משתתפים

נותן חסות ושותפים

Guardant Health, Inc. נותן חסות

זרועות והתערבויות

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.

התערבויות

בדיקה אבחנתית Shield Blood Test for colo-rectal cancer Screening
Shield Blood Test for colo-rectal cancer Screening

מדדי תוצאה

מדד תוצאה ראשוני
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
מסגרת זמן 33-42 Months Post-Enrollment

תאריכים

תאריכים
תאריך התחלה	14 ביולי 2025 (בפועל)
סיום ראשוני	1 בספטמבר 2030 (משוער)
סיום	1 בדצמבר 2030 (משוער)
פורסם לראשונה	17 במרץ 2025 (בפועל)
עודכן לאחרונה	7 באוגוסט 2026
התוצאות פורסמו	לא צוין ברשומת המרשם
המצב אומת לאחרונה	אוגוסט 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

58 אתרים מגייסים

United States

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

19 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

7 באוגוסט 2026
אתר נוסף
13 sites added (69 total)
5669

מרשם: ClinicalTrials.gov · NCT########

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