Clinical trial · Observational
Comparison of In-House Methods and Cobas BRAF V600 Mutation Assay in Melanoma Tumor Samples
Evaluation of Concordance Between the Methods Used in INCa Platforms and the Cobas® 4800 BRAF V600 Mutation Test for Detection of BRAF V600 Mutations in Melanoma in Real Life Setting
NCT01744860CI-TRIAL-00021517completedResults postedClinicalTrials.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)
This non-interventional study will compare the Cobas BRAF V600 mutation assay with in-house methods used in molecular laboratories for the assessment of the BRAF mutation status in melanoma tumor samples. No patients will be enrolled in this study. Data will be collected for approximately 6 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- INCa molecular genetics laboratory "in-house" methods
- description
- BRAF V600 mutations were analysed using INCa (Institut National du Cancer \[French National Cancer Institute\]) molecular genetics laboratories using "in-house" methods
- label
- Cobas 4800 Mutation Test
- description
- BRAF V600 mutations were analysed using Cobas 4800 mutation test
Primary outcomes (1)
- measure
- BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories
- timeFrame
- Up to 6 months
- description
- BRAF V600 mutation status was determined by INCa molecular laboratories "in-house" methods and Cobas 4800 BRAF V600 mutation test. Samples were analysed as V600 mutation, No V600 mutation and Non evaluable. Additionally, the type of V600 mutation (E, K, R, D, E2, other V600 mutation, not specified) was also evaluated only by INCa molecular laboratory "in-house" method.
Secondary outcomes (28)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: No patients are enrolled. Use of tumor samples only. * Histologically proven melanoma tumor sample * Any type of tumor sample: biopsy or surgical specimen of primary tumor or metastasis * Tumor samples must be fixed and paraffin-embedded. Exclusion Criteria: No patients are enrolled. Use of tumor samples only. * Fixative unknown
References
Publications (0)
Data not yet available
No reference posted for this study.