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

Malignant Melanoma Clinical Trial

Official title:

Evaluation of Concordance Between the Cobas® BRAF V600 Mutation Assay and the Methods Used in INCa Platforms for Detection of BRAF V600 Mutations in Melanoma in Real Life Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744860
• Other study ID #: ML28471
• Status: Completed
• Phase: N/A
• First received: December 6, 2012
• Last updated: November 2, 2015
• Start date: December 2012
• Est. completion date: April 2013

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BRAF mutation status of melanoma tumor samples according to cobas® 4800 BRAF V600 Mutation Test vs. INCa laboratories molecular genetics platform		Approximately 6 months	No
Secondary	Type of tumor sample		Approximately 6 months	No
Secondary	Type of pre-analytical method used in the preparation of the tumor sample for BRAF V600 mutation detection		Approximately 6 months	No
Secondary	Final result for BRAF V600 mutation detection		Approximately 6 months	No