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GRAIL-001:Solid and Liquid Tumors: Newly Diagnosed With No Treatment Started, Observation

The Circulating Cell-free Genome Atlas (CCGA) Study

Objective

Overview

GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing cancer from non-cancer.

Key Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.
    • Age 20 years or older
    • Able to provide a written informed consent

    Exclusion Criteria for Non-Cancer Arm Subjects:

    • Known current or prior diagnosis of cancer except non-melanoma skin cancer
    • Oral or IV corticosteroid use in past 14 days prior to blood draw
    • Pregnancy (by self-report)
    • Current febrile illness
    • Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.
    • Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
    • Poor health status or unfit to tolerate blood draw

    Inclusion Criteria for Cancer Arm Subjects:

    • Age 20 years or older
    • Able to provide a written informed consent

    Have either of the following:

    A. Confirmed cancer diagnosis (any stage I-IV, as well as carcinoma in situ (CIS) within 90 days, prior to study blood draw, based upon assessment of a pathological specimen

    OR

    B. A high suspicion for a cancer diagnosis by clinical and/or radiological assessment, with planned biopsy or surgical resection to establish a definitive diagnosis within 6 weeks (42 days) after study blood draw

    Exclusion Criteria for Cancer Arm Subjects:

    • Known prior diagnosis of cancer except non-melanoma skin cancer
    • Currently receiving, or ever received, any of the following therapies to treat their current cancer: surgical management of cancer beyond that required to establish the cancer diagnosis; local, regional or systemic chemotherapy including chemoembolization; targeted therapy, immunotherapy including cancer vaccines; hormone therapy; or radiation therapy
    • Pregnancy (by self-report)
    • Current febrile illness
    • Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.
    • Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
    • Poor health status or unfit to tolerate blood draw

    Phase: N/A

    Learn More

    ClinicalTrials.Gov

    IRB Protocol Number
    GRAIL-001
    Principal Investigator(s)
    Rosanna Lapham, MD

    Clinical Trial Categories

    • Precision Medicine- Rare Tumors
    Sponsor(s)
    GRAIL
    How to Participate

    Rosanna Lapham

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