N/A
N=420
Comparison of In-House Methods and Cobas BRAF V600 Mutation Assay in Melanoma Tumor Samples
Malignant Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01744860 ↗Enrolled (actual)
420
Serious AEs
—
Results posted
Mar 2016
Primary outcome: Primary: BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories — 150; 143; 264; 266 number of samples
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories |
150; 143; 264; 266; 6; 11 | — |
| SECONDARY Tumor Sample Characteristics-Type of Tumor Sample |
87; 333 | — |
| SECONDARY Tumor Sample Characteristics - Source of Tumor Sample |
182; 238 | — |
| SECONDARY Type of Pathology Laboratory Performing the Fixation or Embedding-Pre-analytical Method |
183; 237 | — |
| SECONDARY Time From Sampling to Fixation- Pre-analytical Method |
140; 72; 3; 205 | — |
| SECONDARY Type of Fixative Used- Pre-analytical Method |
19; 10; 389; 2 | — |
| SECONDARY Fixation Duration by Pre-analytical Method |
25; 107; 82; 206 | — |
| SECONDARY Slice Thickness by Pre-analytical Method |
7.1 | — |
| SECONDARY Dewaxing by Pre-analytical Method |
0; 39; 381 | — |
| SECONDARY Necrosis Percentage Determination by Pre-analytical Method |
3.6 | — |
| SECONDARY Percentage of Tumor Cells by Pre-analytical Method |
70.8 | — |
| SECONDARY Tumor Samples With Presence of Melanin by Pre-analytical Method |
127; 43; 19; 202 | — |
| SECONDARY DNA Extraction - Extraction Method by Pre-analytical Method |
188; 232 | — |
| SECONDARY Median DNA Elution Volume by Pre-analytical Method |
100 | — |
| SECONDARY Mean DNA Concentration by Pre-analytical Method |
155.25 | — |
| SECONDARY Amount of DNA by Pre-analytical Method |
11816 | — |
| SECONDARY Size of Amplicons Used by "In-house" Analytical Method |
120 | — |
| SECONDARY Method of Mutation Detection by "In-house" Analytical Method |
128; 118; 67; 26; 30; 51 | — |
| SECONDARY Number of Samples Punched in In-house Analytical Method |
117; 303 | — |
| SECONDARY Mean Number of Slices Per Sample Used for "In-house"- Analytical Method |
2.6 | — |
| SECONDARY Median Time Between Receipt of Samples and Determination of Result by "In-house" Analytical Method |
7 | — |
| SECONDARY Technician Work Time Between DNA Extraction and Result by "In-house" Analytical Method |
7 | — |
| SECONDARY Mean DNA Concentration as Measured by COBAS 4800 BRAF V600 Mutation Test-Analytical Method |
64.62 | — |
| SECONDARY Punch Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method |
45; 375 | — |
| SECONDARY Number of Slices Used When No Punch Was Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method |
2.3 | — |
| SECONDARY Median Time Between Receipt of Sample and Determination of Result by Cobas 4800 BRAF V600 Mutation Test -Analytical Method |
6 | — |
| SECONDARY Technician Work Time Between DNA Extraction and Result by Cobas 4800 BRAF V600 Mutation Test - Analytical Method |
5 | — |
| SECONDARY Management of Discordance- Method Used to Manage Discordance |
7; 6; 4; 2; 2; 2 | — |
| SECONDARY Management of Discordance-Final Result for BRAF V600 Mutation Detection |
19; 7; 2 | — |
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
Data sourced from ClinicalTrials.gov (NCT01744860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.