Clinical trial NCT01744860: Comparison of In-House Methods and Cobas BRAF V600 Mutation Assay in Melanoma Tumor Samples
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Melanoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-12-07
Enrollment: 420
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: No patients are enrolled in this study. Use of melanoma tumor samples.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories
timeFrame: Up to 6 months
Secondary outcomes:
measure: Tumor Sample Characteristics-Type of Tumor Sample
timeFrame: Up to 6 months
measure: Tumor Sample Characteristics - Source of Tumor Sample
timeFrame: Up to 6 months
measure: Type of Pathology Laboratory Performing the Fixation or Embedding-Pre-analytical Method
timeFrame: Up to 6 months
measure: Time From Sampling to Fixation- Pre-analytical Method
timeFrame: Up to 6 months
measure: Type of Fixative Used- Pre-analytical Method
timeFrame: Up to 6 months
measure: Fixation Duration by Pre-analytical Method
timeFrame: Up to 6 months
measure: Slice Thickness by Pre-analytical Method
timeFrame: Up to 6 months
measure: Dewaxing by Pre-analytical Method
timeFrame: Up to 6 Months
measure: Necrosis Percentage Determination by Pre-analytical Method
timeFrame: Up to 6 months
measure: Percentage of Tumor Cells by Pre-analytical Method
timeFrame: Up to 6 months
measure: Tumor Samples With Presence of Melanin by Pre-analytical Method
timeFrame: Up to 6 months
measure: DNA Extraction - Extraction Method by Pre-analytical Method
timeFrame: Up to 6 months
measure: Median DNA Elution Volume by Pre-analytical Method
timeFrame: Up to 6 months
measure: Mean DNA Concentration by Pre-analytical Method
timeFrame: Up to 6 months
measure: Amount of DNA by Pre-analytical Method
timeFrame: Up to 6 months
measure: Size of Amplicons Used by "In-house" Analytical Method
timeFrame: Up to 6 months
measure: Method of Mutation Detection by "In-house" Analytical Method
timeFrame: Up to 6 months
measure: Number of Samples Punched in In-house Analytical Method
timeFrame: Up to 6 months
measure: Mean Number of Slices Per Sample Used for "In-house"- Analytical Method
timeFrame: Up to 6 months
measure: Median Time Between Receipt of Samples and Determination of Result by "In-house" Analytical Method
timeFrame: Up to 6 months
measure: Technician Work Time Between DNA Extraction and Result by "In-house" Analytical Method
timeFrame: Up to 6 months
measure: Mean DNA Concentration as Measured by COBAS 4800 BRAF V600 Mutation Test-Analytical Method
timeFrame: Up to 6 months
measure: Punch Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method
timeFrame: Up to 6 months
measure: Number of Slices Used When No Punch Was Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method
timeFrame: Up to 6 months
measure: Median Time Between Receipt of Sample and Determination of Result by Cobas 4800 BRAF V600 Mutation Test -Analytical Method
timeFrame: Up to 6 months
measure: Technician Work Time Between DNA Extraction and Result by Cobas 4800 BRAF V600 Mutation Test - Analytical Method
timeFrame: Up to 6 months
measure: Management of Discordance- Method Used to Manage Discordance
timeFrame: Up to 6 months
measure: Management of Discordance-Final Result for BRAF V600 Mutation Detection
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Boulogne Billancourt
country: France
city: Colmar
country: France
city: Lille
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Nantes
country: France
city: Paris
country: France
city: Pessac
country: France
city: Rouen
country: France
city: Vandoeuvre Les Nancy
country: France
city: Villejuif
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: