N/A
N=264
Study to Analyze Mutations in V600 BRAF Oncogen in Participants With Metastatic Melanoma
Metastatic Cancers
Bottom Line
View on ClinicalTrials.gov: NCT02663232 ↗Enrolled (actual)
264
Serious AEs
—
Results posted
Apr 2016
Primary outcome: Primary: Percentage of Participants With V600 BRAF Mutation Status — 41.3; 58.3; 0.4 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With V600 BRAF Mutation Status |
41.3; 58.3; 0.4 | — |
| SECONDARY Percentage of Participants Categorized by Melanoma Stage |
14.4; 19.3; 13.3; 22.7; 29.9 | 0.001 sig |
| SECONDARY Percentage of Participants With Family History of Melanoma |
5.7 | 0.240 |
| SECONDARY Percentage of Participants With Sun Exposure |
49.2; 12.3; 60.8; 26.9; 13.6 | 0.719 |
| SECONDARY Percentage of Participants Categorized by Primary Tumor Location |
9.1; 22.0; 28.4; 14.4; 6.8; 4.2 | 0.262 |
| SECONDARY Percentage of Participants Categorized By LDH Level |
20.1; 51.5; 28.4 | 0.313 |
| SECONDARY Median Time Since Diagnosis of Melanoma |
1.0 | 0.291 |
| SECONDARY Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites) |
62.9; 34.1; 2.3; 0.8 | 0.164 |
| SECONDARY Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other) |
73.5; 22.3; 3.4; 0.8 | 0.505 |
| SECONDARY Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others) |
92.8; 5.3; 1.9 | 0.701 |
| SECONDARY Percentage of Participants Categorized by Breslow Thickness |
5.7; 14.4; 22.3; 27.3; 30.3 | 0.683 |
| SECONDARY Percentage of Participants With Ulceration |
41.7; 26.1; 32.2 | 0.615 |
| SECONDARY Percentage of Participants With Regression |
9.5; 53.0; 37.5 | 0.949 |
| SECONDARY Percentage of Participants With Vascular Invasion |
8.3; 58.7; 33.0 | 0.374 |
| SECONDARY Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others) |
93.1; 6.8 | — |
| SECONDARY Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others) |
96.2; 3.8 | — |
| SECONDARY Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique |
12.1; 31.4; 33.0; 23.5 | — |
| SECONDARY Percentage of Participants With Adequate Quality/Quantity of Tumor Sample |
100.0 | — |
Summary
This is a national, multicenter, cross-sectional epidemiological study in adult Spanish participants diagnosed with advanced or metastatic melanoma.
Eligibility Criteria
Inclusion Criteria
- Valid tumor samples from participants diagnosed with Stage IIIc or IV melanoma
- Written informed consent granted
Exclusion Criteria
- Do not fulfill one or more inclusion criteria
Data sourced from ClinicalTrials.gov (NCT02663232). 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.