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.
Study Type
OBSERVATIONAL
Enrollment
420
Unnamed facility
Boulogne-Billancourt, France
Unnamed facility
Colmar, France
Unnamed facility
Lille, France
Unnamed facility
Lyon, France
BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories
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.
Time frame: Up to 6 months
Tumor Sample Characteristics-Type of Tumor Sample
The type of tumor sample used for evaluation of BRAF V600 mutation whether it was a biopsy or surgical specimen were reported
Time frame: Up to 6 months
Tumor Sample Characteristics - Source of Tumor Sample
The source of tumor sample for BRAF V600 mutation detection whether taken from internal or external pathology laboratory were reported
Time frame: Up to 6 months
Type of Pathology Laboratory Performing the Fixation or Embedding-Pre-analytical Method
The external or internal pathology laboratories involved in the process of fixation or embedding of the tumor sample was evaluated.
Time frame: Up to 6 months
Time From Sampling to Fixation- Pre-analytical Method
Time taken from the sampling to the fixation of the tumor sample was reported in range of 0-2 hours, 2-6 hours, \>6 hours and unknown. Number of samples falling in each of the class were reported.
Time frame: Up to 6 months
Type of Fixative Used- Pre-analytical Method
The different types of fixative Excell, formol, alcohol formol acetic acid and other, used to fix the tumor samples were reported.
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Unnamed facility
Marseille, France
Unnamed facility
Montpellier, France
Unnamed facility
Nantes, France
Unnamed facility
Paris, France
Unnamed facility
Pessac, France
Unnamed facility
Rouen, France
...and 2 more locations
Time frame: Up to 6 months
Fixation Duration by Pre-analytical Method
Fixation duration is defined as the amount of time required in hours for the fixation of a samples. The fixation duration was categorized as \<6 hours, 6-24 hours and \>24 hours and unknown. Number of samples falling in each category were reported
Time frame: Up to 6 months
Slice Thickness by Pre-analytical Method
Slice thickness of all the tumour samples was measured. The slice thickness was measured in micrometer.
Time frame: Up to 6 months
Dewaxing by Pre-analytical Method
Dewaxing is a method to recover the DNA from samples. Dewaxing information was collected as "Yes, No or Missing"
Time frame: Up to 6 Months
Necrosis Percentage Determination by Pre-analytical Method
The percentage of necrosis defined as the death of one or more cells in the analysed zone was reported.
Time frame: Up to 6 months
Percentage of Tumor Cells by Pre-analytical Method
The percentage of tumor cells in the given tumor sample were reported.
Time frame: Up to 6 months
Tumor Samples With Presence of Melanin by Pre-analytical Method
The tumor samples with presence of melanin were categorized as Important, Few, Medium and Absent.
Time frame: Up to 6 months
DNA Extraction - Extraction Method by Pre-analytical Method
This method assessed DNA from the tumor samples was extracted by Automated method or Manual method.
Time frame: Up to 6 months
Median DNA Elution Volume by Pre-analytical Method
Median DNA elution volume microliters \[mcl\] was reported.
Time frame: Up to 6 months
Mean DNA Concentration by Pre-analytical Method
The DNA concentration in the tissue elute was measured in nanogram per microliter (ng/mcL).
Time frame: Up to 6 months
Amount of DNA by Pre-analytical Method
The total DNA concentration extracted from the tissue was measured in nanogram (ng).
Time frame: Up to 6 months
Size of Amplicons Used by "In-house" Analytical Method
The method described the size of amplicon used. It was measured in base pairs (bp).
Time frame: Up to 6 months
Method of Mutation Detection by "In-house" Analytical Method
Allele-specific PCR, High Resolution Melting (HRM) + Sanger sequencing, Pyrosequencing, Sanger sequencing, Real time PCR, SNaPshot were used for BRAF V600 mutation detection.
Time frame: Up to 6 months
Number of Samples Punched in In-house Analytical Method
Total number of samples for whom punch was used in 'in-house analytical' method are reported.
Time frame: Up to 6 months
Mean Number of Slices Per Sample Used for "In-house"- Analytical Method
The mean of number of slices per sample when no punch was used are reported.
Time frame: Up to 6 months
Median Time Between Receipt of Samples and Determination of Result by "In-house" Analytical Method
This In-house analytical method measured the time between receipt of samples to the result determination. It measured the time in days.
Time frame: Up to 6 months
Technician Work Time Between DNA Extraction and Result by "In-house" Analytical Method
The working time required by the technician from the time of DNA extraction to the time to obtain the results was measured in hours.
Time frame: Up to 6 months
Mean DNA Concentration as Measured by COBAS 4800 BRAF V600 Mutation Test-Analytical Method
The DNA concentration as assessed by COBAS 4800 BRAF V600 Mutation assay was reported. The unit used to measure the DNA concentration was nanogram/microlitre (ng/mcl)
Time frame: Up to 6 months
Punch Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method
The punch done during Cobas 4800 BRAF V600 Mutation Test on the sample was described as Yes or No.
Time frame: Up to 6 months
Number of Slices Used When No Punch Was Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method
This describes the Cobas 4800 BRAF V600 Mutation Test, for the mean of number of slices when No punch method, was used. Of the 420 samples, punch was Yes, for 45 samples and punch was No, for 375 samples.
Time frame: Up to 6 months
Median Time Between Receipt of Sample and Determination of Result by Cobas 4800 BRAF V600 Mutation Test -Analytical Method
This analytical method for cobas 4800 BRAF V600 Mutation Test measured the time between receipt of samples to the result determination. It measured the time in days.
Time frame: Up to 6 months
Technician Work Time Between DNA Extraction and Result by Cobas 4800 BRAF V600 Mutation Test - Analytical Method
This cobas 4800 BRAF V600 Mutation Test analytical method measures the working time required by the technician from the time of DNA extraction to the time to obtain the results. The time duration was measured in hours.
Time frame: Up to 6 months
Management of Discordance- Method Used to Manage Discordance
Crossing DNA, DNA from In-House method analysed with cobas, SNaPshot, DNA from cobas analysed with In-House method, external site control test, Sanger sequencing, Kit CE-IVD Therascreen RGQ Qiagen, Kit Therascreen RGQ BRAF + Pyrosequencing by another platform (PF), Pyrosequencing, Mutation detection On Another Block, (primitive tumor \[prm. tmr\]), Sequencing And Therascreen kit (Qiagen) were used for management of discordance between "in-house" method and Cobas 4800 mutation test.
Time frame: Up to 6 months
Management of Discordance-Final Result for BRAF V600 Mutation Detection
The final results obtained by discordance management of the 28 discordant samples were BRAF V600 mutation, No BRAF V600 mutation and Non-evaluable. These results were further assessed by the Investigator and interpreted as final result.
Time frame: Up to 6 months