Comparison of In-House Methods and Cobas BRAF V600 Mutation Assay in Melanoma Tumor Samples

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Malignant Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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INCa molecular genetics laboratory "in-house" methods

BRAF V600 mutations were analysed using INCa (Institut National du Cancer \[French National Cancer Institute\]) molecular genetics laboratories using "in-house" methods

No interventions assigned to this group

Cobas 4800 Mutation Test

BRAF V600 mutations were analysed using Cobas 4800 mutation test

No interventions assigned to this group

Eligibility Criteria

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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.