The Circulating Cell-free Genome Atlas Study (CCGA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02889978|
Recruitment Status : Active, not recruiting
First Posted : September 7, 2016
Last Update Posted : July 12, 2021
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||15254 participants|
|Official Title:||The Circulating Cell-free Genome Atlas Study|
|Actual Study Start Date :||August 4, 2016|
|Estimated Primary Completion Date :||March 2024|
|Estimated Study Completion Date :||March 2024|
Participants with new diagnosis of cancer (multiple tumor types) from which a blood sample and contemporaneous FFPE tumor tissue will be collected.
Participants with no known diagnosis or past history of cancer from which a blood sample will be collected.
- To collect and study clinically-annotated biospecimens, specifically peripheral blood and contemporary tumor tissue when available, to characterize cfNA profiles from deep sequencing and to estimate the population heterogeneity in two arms of the study. [ Time Frame: 30 months ]
- To develop and evaluate models for discriminating cancer versus non-cancer and tissue of origin. [ Time Frame: 30 months ]
- To evaluate concordance of variants identified in sequencing of tumor tissue and cfNA sequencing results in plasma from the same subject. [ Time Frame: 30 months ]
- 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 participants. [ Time Frame: Year 1, 2, 3, 4, 5 ]
- 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. [ Time Frame: Year 1, 2, 3, 4, 5 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889978
|Study Director:||Kathryn N Kurtzman, MD||GRAIL, LLC|