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Title The Circulating Cell-free Genome Atlas (CCGA) Study

IRB GRAIL1Z16

CC 16-1591

Hospital Main Campus, Main Campus

Primary Objectives:

To collect and study clinically annotated biospecimens, specifically peripheral blood (from cancer and non-cancer subjects) and contemporary tumor tissue when available (from cancer subjects), to characterize cfNA profiles from deep sequencing and to estimate the population heterogeneity in the two arms of the study:
- In the cancer arm, by tumor type (and sub-types), tumor stage, disease burden, and aggressiveness (based on follow-up)
- In the non-cancer arm, by age, gender, ethnicity, smoking status, body mass index, and other known cancer risk factors.
To develop and evaluate models for discriminating cancer versus non-cancer and tissue of origin. Pre-specified interim analyses will be performed to adjust sample sizes accordingly in an adaptive fashion.
To evaluate concordance of variants identified in sequencing of tumor tissue and cfNA sequencing results in plasma from the same subject.

Secondary Objectives:

To explore the relationship between genomic results and clinical outcomes based on collection of longitudinal information (at least annually for up to 5 years) from medical records for all consenting subjects.
To enable assessment of the performance of an analytically validated clinical laboratory version of the NGS assay (under development) to detect circulating tumor DNA (ctDNA) in plasma.

Age 20 years or older
Able to provide a written informed consent and who understand and agree to all study procedures required
Cancer arm:
- Either of the following:
  - Diagnosis of histologically confirmed cancer present in the patient (any stage I-IV, as well as carcinoma in situ (CIS) - see Appendix A) with no prior 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 cancer therapy and are scheduled for surgery or biopsy to retrieve cancer tissue
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.

Currently receiving or ever received any of the following prior 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

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