Early Detection: CCGA

May 09, 2017

Sponsor: GRAIL, Inc.

Number: GRAIL

This is a prospective, multi-center, observational study with collection of de-identified bio specimens and clinical data from at least 10,000 participants from clinical networks in the United States. A prospective study watches for outcomes, such as the development of a disease, during the study period and relates this to other factors such as suspected risk or protection factor. The study will enroll at least 7000 cancer subjects with multiple solid tumor types (the CANCER arm) and at least 3000 representative subjects without a clinical diagnosis of cancer (the NON-CANCER arm). Cancer subjects with a new diagnosis and no prior systemic therapy will be recruited. Clinical data relevant to cancer status are collected from all participants and their medical record at baseline, and subsequently from the medical record at intermittent future time points, at least annually for up to 5 years. The study test(s) to be used in this protocol are next generation sequencing (NGS)-based assay(s) that are under investigation and development at GRAIL.

Who’s eligible:

Cancer group:

Either of the following:

• New diagnosis of histologically confirmed cancer (any stage I-IV, as well as carcinoma in situ (CIS)), across multiple solid tumor types with no prior systemic 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 systemic cancer therapy and are scheduled for surgery.

Has or will have a medically obtained pathological tumor specimen from core needle or surgical biopsy and/or surgical resection, within 4 weeks (28 days) of study blood draw and pre-treatment.

Non-Cancer group:

• At least one guideline recommended cancer screening test documented in the medical record, if indicated for age and gender (eg, pap smear, mammography, and/or colonoscopy.
• This study is for patients age 20 and older.

Available at: The Hospital of Central Connecticut and Hartford Hospital.