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

Roche

Status: Completed

Conditions: Malignant Melanoma

Study type: Observational

Funder types: Industry

Identifiers

NCT01744860

ML28471

Details and patient eligibility

About

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.

Enrollment: 420 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

420 participants in 2 patient groups

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

Cobas 4800 Mutation Test

Description:

BRAF V600 mutations were analysed using Cobas 4800 mutation test