Clinical trial · Observational
The STRIVE Study: Development of a Blood Test for Early Detection of Multiple Cancer Types
The STRIVE Study: Breast Cancer Screening Cohort for the Development of Assays for Early Cancer Detection
NCT03085888CI-TRIAL-00080921completedClinicalTrials.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 high-intensity sequencing of circulating cell-free nucleic acids (cfNAs) to develop blood tests to detect cancer early. The purpose of this study is to validate the ability of the pre-specified GRAIL Test to detect breast cancer and other invasive cancers, including hematologic malignancies, that will occur within one year of the first study blood draw.
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 (1)
- label
- Prospective Cohort
- description
- This is a prospectively enrolling cohort study with a pre-specified molecular analysis plan. A stratified case-cohort design will be employed to select cancer cases and non-cancer subjects who will be assayed. All cases of cancer (breast and non-breast cancer) will be selected. A random subset of the overall study cohort will also be selected.
Primary outcomes (2)
- measure
- To evaluate the performance of the pre-specified GRAIL Test to detect invasive cancers (including hematologic malignancies).
- timeFrame
- From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months
- measure
- To refine the predictive algorithms and cut points of the GRAIL test to detect breast and other invasive cancers (including hematologic malignancies).
- timeFrame
- From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women undergoing mammography for screening indications or have an appointment for screening mammography. 2. Participant provides informed consent and expresses understanding of the protocol and its requirements, risks, and discomforts. Exclusion Criteria: None.
References
Publications (1)
- DERIVEDLiu MC, Oxnard GR, Klein EA, Swanton C, Seiden MV; CCGA Consortium. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020 Jun;31(6):745-759. doi: 10.1016/j.annonc.2020.02.011. Epub 2020 Mar 30. PMID 33506766