NCT02889978

The Circulating Cell-free Genome Atlas Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 15,254 (actual)
• Sponsor: GRAIL, Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Neoplasms
• Cancer

Timeline

• Start date: 2016-08-04
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2016-09-07
• Last updated: 2023-09-13

Locations

140 sites across 2 countries: United States, Canada