Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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 participants with a new diagnosis of cancer (blood and tumor tissue) and from
participants who do not have a diagnosis of cancer (blood) in order to characterize the
population heterogeneity in cancer and non-cancer participants and to develop models for
distinguishing cancer from non-cancer.
Phase
N/A
Funding Agency/Sponsor
Industrial
Disease
Bone and Soft Tissue Cancers
Enrollment Eligibility
Inclusion Criteria for Non-Cancer Arm Participants:
- Age 20 years or older
- Able to provide a written informed consent
Exclusion Criteria for Non-Cancer Arm Participants:
- 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 Participants:
- 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 or up to 42 days after 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 Participants:
- 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
Accepts Healthy Volunteers
Call +1 (407) 7659589