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Lay Description

The purpose and rationale is to evaluate the safety and performance of the GRAIL Multi-Cancer Early Detection (MCED) Test in an eligible screening population..

Category

  • Healthy Subjects Needed
IRB Number
STUDY00000396
NCT Number
NCT # not yet entered

Eligibility

Eligible Ages
50-75
Eligible Genders
All
Accepts Healthy Volunteers

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply. 1. Participants must be at least 50 years of age, inclusive, at the time of signing the Informed Consent Form (ICF). 2. Informed Consent ● Capable of giving signed and legally effective informed consent as described in Section 5.4, Study Design Schema, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol. Consent provided by a legally authorized representative is not permitted in this protocol.

Exclusion Criteria

Undergoing or referred for diagnostic evaluation due to clinical suspicion for cancer (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the basis of a suspicious imaging abnormality). 2. Personal history of invasive solid tumor or hematologic malignancy, diagnosed within the 3 years prior to expected enrollment date, or diagnosed greater than 3 years prior to expected enrollment date and never treated. ● Individuals with a diagnosis of non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin are not excluded. 3. Prior/Concurrent Concomitant Therapy (Medications/Treatments):● Definitive treatment for invasive solid tumor or hematologic malignancy within the 3 years prior to expected enrollment date. Adjuvant hormone therapy for cancer (e.g. for breast or prostate cancer) is not an exclusion criterion. 4. Individuals who will not be able to comply with the protocol procedures. 5. Individuals who are not currently registered patients at a participating center. 6. Previous or current participation in another GRAIL-sponsored study. “Participation” is defined as having signed consent and provided a blood sample. 7. Previous or current employees or contractors of GRAIL. 8. Current pregnancy (by self-report of pregnancy status)

Study Design

Arm Groups

Study Contact


Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu

Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu

Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu

Principal Investigator
Ramon Cancino