The Circulating Cell-free Genome Atlas (CCGA) Study
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 Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
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
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
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 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
Learn More
To learn more, visit ClinicalTrials.Gov
Study Type
Phase: N/A
Principal Investigator(s)
Rosanna Lapham, MD
Sponsor(s)
GRAIL