Shield Post-Approval Study Protocol
ConditionColo-rectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-81
SponsorGuardant Health, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
12 months for fecal occult blood test (FOBT) or fecal immunochemical test (FIT)
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Shield Blood Test for colo-rectal cancer Screening
Diagnostic testShield Blood Test for colo-rectal cancer Screening
Treatment groups
3,375 Participants
are divided into 1 treatment groupGroup A: Enrolled Subjects1 intervention
Trial outcomes
Primary outcomes
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
Time frame
33-42 Months Post-EnrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov