The Circulating Cell-free Genome Atlas Study

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-008106
    • Jacksonville, Florida: 16-008106
    • Rochester, Minnesota: 16-008106
    NCT ID: NCT02889978
    Sponsor Protocol Number: GRAIL-001

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

Inclusion Criteria for Non-Cancer Arm Subjects:

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

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:

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

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 the 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20303079

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