Clinical trial · Observational
The Circulating Cell-free Genome Atlas Study
NCT02889978CI-TRIAL-00069522CCGAunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Cancer arm
- description
- Participants with new diagnosis of cancer (multiple tumor types) from which a blood sample and contemporaneous FFPE tumor tissue will be collected.
- label
- Non-cancer arm
- description
- Participants with no known diagnosis or past history of cancer from which a blood sample will be collected.
Primary outcomes (3)
- measure
- 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.
- timeFrame
- 30 months
- measure
- To develop and evaluate models for discriminating cancer versus non-cancer and tissue of origin.
- timeFrame
- 30 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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 or up to 42 days after 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
References
Publications (9)
- DERIVEDSwanton C, Bryce A, Cohn AL, Margolis M, Hubbell E, Sagan A, Venn O, Seiden M. Prognostic Significance of Blood-Based Multicancer Detection in Circulating Tumor DNA: Five-Year Outcomes Analysis. JCO Precis Oncol. 2026 Mar;10(3):e2500725. doi: 10.1200/PO-25-00725. Epub 2026 Mar 12. PMID 41818645
- DERIVEDMahal BA, Margolis M, Hubbell E, Chen C, Venstrom JM, Abran J, Kartlitz JJ, Wyatt AW, Klein EA. A Targeted Methylation-Based Multicancer Early Detection Blood Test Preferentially Detects High-Grade Prostate Cancer While Minimizing Overdiagnosis of Indolent Disease. JCO Precis Oncol. 2024 Aug;8:e2400269. doi: 10.1200/PO.24.00269. PMID 39208374
- DERIVEDBryce AH, Thiel DD, Seiden MV, Richards D, Luan Y, Coignet M, Zhang Q, Zhang N, Hubbell E, Kurtzman KN, Klein EA. Performance of a Cell-Free DNA-Based Multi-cancer Detection Test in Individuals Presenting With Symptoms Suspicious for Cancers. JCO Precis Oncol. 2023 Jul;7:e2200679. doi: 10.1200/PO.22.00679. PMID 37467458
- DERIVEDTang WHW, Yimer H, Tummala M, Shao S, Chung G, Clement J, Chu BC, Hubbell E, Kurtzman KN, Swanton C, Roberts LR. Performance of a targeted methylation-based multi-cancer early detection test by race and ethnicity. Prev Med. 2023 Feb;167:107384. doi: 10.1016/j.ypmed.2022.107384. Epub 2022 Dec 7. PMID 36495927
- DERIVEDShao SH, Allen B, Clement J, Chung G, Gao J, Hubbell E, Liu MC, Swanton C, Tang WHW, Yimer H, Tummala M. Multi-cancer early detection test sensitivity for cancers with and without current population-level screening options. Tumori. 2023 Jun;109(3):335-341. doi: 10.1177/03008916221133136. Epub 2022 Oct 31. PMID 36316952
- DERIVEDBredno J, Lipson J, Venn O, Aravanis AM, Jamshidi A. Clinical correlates of circulating cell-free DNA tumor fraction. PLoS One. 2021 Aug 25;16(8):e0256436. doi: 10.1371/journal.pone.0256436. eCollection 2021. PMID 34432811