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:

  • Age 20 years or older
  • Able to provide a written informed consent and who understand and agree to all study procedures required

Cancer arm:

  1. Either of the following:
    • Diagnosis of histologically confirmed cancer present in the patient (any stage I-IV, as well as carcinoma in situ (CIS)), with no prior systemic cancer therapy and scheduled for surgical resection or non-surgical management OR,
    • Subjects with a high suspicion for cancer diagnosis by clinical and radiological assessment, but without preceding histologic diagnosis, are eligible if they have not received prior systemic cancer therapy and are scheduled for surgery or biopsy to retrieve cancer tissue
  2. Has or will have a medically obtained pathological tumor specimen from core needle or other biopsy or removal of a metastatic mass or node within 90 days prior to study blood draw and/or planned surgical resection within 6 weeks (42 days) after study blood draw and pre-treatment.

Non-Cancer arm: ● Male and female adults with no known prior or current diagnosis of cancer, except non-melanomatous skin cancer.

Exclusion Criteria:

● Currently receiving or ever received any of the following cancer therapies: curative surgical resection, local or systemic chemotherapy, targeted therapy, immunotherapy including cancer vaccines, hormone therapy, or radiation therapy

  • Oral or IV corticosteroids in past 14 days for non-cancer subjects
  • Pregnancy (by self-report of pregnancy status)
  • Current febrile illness
  • Acute exacerbation or flare of an inflammatory condition requiring escalation in therapy
  • 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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