The Circulating Cell-free Genome Atlas Study

This is a prospective, multi-center, observational study with collection of de-identified
biospecimens and clinical data from at least 15,000 participants from clinical networks in
the United States and Canada. The study will enroll approximately 10,500 cancer participants
(CANCER arm) and approximately 4,500 representative participants without a clinical diagnosis
of cancer (NON-CANCER arm). Clinical information, demographics, and medical data relevant to
cancer status are collected from all participants and their medical record at baseline (time
of biospecimen collection), and subsequently from the medical record at intermittent future
time points, at least annually for up to 5 years.

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 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