Clinical trial · Observational
Concordance Between ctDNA Assay and FoundationOne
Study of Concordance Between Circulating Tumor DNA Assay and Foundation One Tissue Analysis For Genomic Alterations
NCT02620527CI-TRIAL-00034068completedClinicalTrials.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)
Foundation Medicine Inc. (FMI) is interested in studying the concordance of genomic alterations between primary and/or metastatic surgical biopsies, and circulating tumor DNA (ctDNA) within different solid tumor types and has been developing an assay in order to do so.
Conditions
Conditions (5)
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 |
| Circulating Tumor DNA | — | UNRESOLVED | — |
| Genomic Alterations | — | UNRESOLVED | — |
| Genomic Testing | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Whether new ctDNA assay can detect genomic alterations in peripheral blood that are consistent with those detected by FoundationOne in matched solid tumor samples
- timeFrame
- 6-12 months
- measure
- Determine which tumor types are most amenable to detection using peripheral blood ctDNA assay
- timeFrame
- 6-12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have had a solid tumor biopsy isolated for analysis by FoundationOne under their standard clinical care Exclusion Criteria: * Tumor specimens where no cancer representative of the diagnosis is found in submitted tissue * Tumor specimens where insufficient DNA (\<50 ng) is provided to run the FoundationOne test. * Tumor specimens with ≤20% tumor nuclei (all specimens).
References
Publications (1)
- DERIVEDZhou C, Yuan Z, Ma W, Qi L, Mahavongtrakul A, Li Y, Li H, Gong J, Fan RR, Li J, Molmen M, Clark TA, Pavlick D, Frampton GM, Forcier B, Moore EH, Shelton DK, Cooke M, Ali SM, Miller VA, Gregg JP, Stephens PJ, Li T. Clinical utility of tumor genomic profiling in patients with high plasma circulating tumor DNA burden or metabolically active tumors. J Hematol Oncol. 2018 Nov 6;11(1):129. doi: 10.1186/s13045-018-0671-8. PMID 30400986