Cancer Screening Cohort for Training and Validation of the GRAIL Test

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
    • La Crosse, Wisconsin: 16-008471
    • Scottsdale/Phoenix, Arizona: 16-008471
    • Jacksonville, Florida: 16-008471
    • Rochester, Minnesota: 16-008471
    Sponsor Protocol Number: GRAIL-002

About this study

This protocol describes a long-term prospective observational cohort study of women undergoing screening mammography (defined as digital mammography or tomosynthesis) that will be used to train and validate the GRAIL Test (cfNA assay alone, or in combination with clinical and radiologic variables, and germline variants) for detection of invasive breast cancer (IBC). The training phase will utilize the first 33% of enrolled women. The remaining women will be included in the validation phase.

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:

  1. Patient has an appointment for screening mammography, as referred or recommended by a health care provider.
  2. Screening mammogram is received at same facility within 28 days of blood draw (i.e. blood may be drawn up to 28 days before or 28 days after the screening mammogram).
  3. Patient provides informed consent and expresses understanding of the protocol and its requirements, risks, and discomforts.
  4. Patient provides consent to participate in long-term follow-up, such as contact via study portal, mail, or phone, for further self-reported information regarding cancer diagnoses, change to health plan or residential status, or requests for additional blood draws and linkage to state cancer registries and administrative databases. 

Exclusion Criteria: 

  1. Inability on the part of the patient to understand the informed consent or be compliant with the protocol.
  2. Breast biopsy to evaluate abnormal breast imaging results has occurred prior to a planned research blood draw.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

La Crosse, Wis.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Open for enrollment

Contact information:

Ashley Pitzer

(608)392-9521

Pitzer.Ashley@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Open for enrollment

Contact information:

Joy Few

(480)342-2131

Few.Joy@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Open for enrollment

Contact information:

Santo Maimone M.D.

(844)366-9738

STRIVE@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Open for enrollment

Contact information:

Minetta Liu M.D.

(844)366-9738

STRIVE@mayo.edu

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions