Trial Outcomes & Findings for Study to Analyze Mutations in V600 BRAF Oncogen in Participants With Metastatic Melanoma (NCT NCT02663232)
NCT ID: NCT02663232
Last Updated: 2023-07-03
Results Overview
Presence or absence of mutations in the V600 BRAF oncogene was determined in all eligible participants. Data collection and management of BRAF mutation testing was carried out using the Biomarker point® online platform. The platform was used as an electronic case report form (e-CRF) for collecting information in electronic format via a website. Percentage of participants with BRAF mutation status (mutated BRAF, wild type, not available) were reported.
COMPLETED
264 participants
Day 1
2023-07-03
Participant Flow
Participant milestones
| Measure |
Metastatic Melanoma
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Overall Study
STARTED
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264
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Overall Study
COMPLETED
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264
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Analyze Mutations in V600 BRAF Oncogen in Participants With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Age, Continuous
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68.0 years
n=5 Participants
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Sex: Female, Male
Female
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113 Participants
n=5 Participants
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Sex: Female, Male
Male
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151 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 1Population: All enrolled participants were included in the analysis.
Presence or absence of mutations in the V600 BRAF oncogene was determined in all eligible participants. Data collection and management of BRAF mutation testing was carried out using the Biomarker point® online platform. The platform was used as an electronic case report form (e-CRF) for collecting information in electronic format via a website. Percentage of participants with BRAF mutation status (mutated BRAF, wild type, not available) were reported.
Outcome measures
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Percentage of Participants With V600 BRAF Mutation Status
Mutated BRAF
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41.3 percentage of participants
Interval 35.3 to 47.5
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Percentage of Participants With V600 BRAF Mutation Status
Wild type
|
58.3 percentage of participants
Interval 52.1 to 64.3
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Percentage of Participants With V600 BRAF Mutation Status
Not available
|
0.4 percentage of participants
Interval 0.02 to 2.4
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SECONDARY outcome
Timeframe: Day 1Population: All participants enrolled in the study were included in the analysis.
Melanoma stages were categorized (according to American Joint Committee on Cancer \[AJCC\]) as IIIc (advanced stage of melanoma), M1a (metastases to skin, subcutaneous, or distant lymph nodes, normal lactate dehydrogenase (LDH) level, M1b (lung metastases, normal LDH) and M1c (metastases to all other visceral sites and normal LDH or distant metastases to any site combined with an elevated serum LDH level). Of these Stage IIIc was used as the referral category for comparisons.
Outcome measures
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Percentage of Participants Categorized by Melanoma Stage
IIIc
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14.4 percentage of participants
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Percentage of Participants Categorized by Melanoma Stage
M1a
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19.3 percentage of participants
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Percentage of Participants Categorized by Melanoma Stage
M1c
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22.7 percentage of participants
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Percentage of Participants Categorized by Melanoma Stage
M1b
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13.3 percentage of participants
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Percentage of Participants Categorized by Melanoma Stage
Missing data
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29.9 percentage of participants
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SECONDARY outcome
Timeframe: Day 1Population: All participants enrolled in the study were included in the analysis.
Outcome measures
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Percentage of Participants With Family History of Melanoma
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5.7 percentage of participants
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SECONDARY outcome
Timeframe: Day 1Population: All participants enrolled in the study were included in the analysis.
Data were obtained to classify the population with sun exposure as those with low, intermittent or chronic exposure. For the sub-analysis of low, intermittent and chronic exposure, percentages were calculated based on the population with any sun exposure.
Outcome measures
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Percentage of Participants With Sun Exposure
Any exposure (n=264)
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49.2 percentage of participants
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Percentage of Participants With Sun Exposure
Low exposure (n=130)
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12.3 percentage of participants
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Percentage of Participants With Sun Exposure
Intermittent exposure (n=130)
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60.8 percentage of participants
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Percentage of Participants With Sun Exposure
Chronic exposure (n=130)
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26.9 percentage of participants
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Percentage of Participants With Sun Exposure
Missing data (n=264)
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13.6 percentage of participants
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SECONDARY outcome
Timeframe: Day 1Population: All participants enrolled in the study were included in the analysis.
Primary tumor location included limbs (upper and lower extremities), trunk, head/neck, mucosa, uveal, acral, other (other than these specified locations), unknown (exact location unknown), and not available.
Outcome measures
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Percentage of Participants Categorized by Primary Tumor Location
Uveal
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4.2 percentage of participants
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Percentage of Participants Categorized by Primary Tumor Location
Limbs (Upper extremities)
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9.1 percentage of participants
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Percentage of Participants Categorized by Primary Tumor Location
Limbs (Lower extremities)
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22.0 percentage of participants
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Percentage of Participants Categorized by Primary Tumor Location
Trunk
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28.4 percentage of participants
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Percentage of Participants Categorized by Primary Tumor Location
Head/Neck
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14.4 percentage of participants
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Percentage of Participants Categorized by Primary Tumor Location
Mucosa
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6.8 percentage of participants
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Percentage of Participants Categorized by Primary Tumor Location
Acral
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1.1 percentage of participants
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Percentage of Participants Categorized by Primary Tumor Location
Other
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0.4 percentage of participants
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Percentage of Participants Categorized by Primary Tumor Location
Unknown
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8.7 percentage of participants
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Percentage of Participants Categorized by Primary Tumor Location
Not available
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6.1 percentage of participants
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SECONDARY outcome
Timeframe: Day 1Population: All participants enrolled in the study were included in the analysis.
Normal LDH levels range from 140 units per liter (U/L) to 280 U/L.
Outcome measures
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Percentage of Participants Categorized By LDH Level
Normal
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20.1 percentage of participants
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Percentage of Participants Categorized By LDH Level
High
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51.5 percentage of participants
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Percentage of Participants Categorized By LDH Level
Unknown
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28.4 percentage of participants
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SECONDARY outcome
Timeframe: Day 1Population: All participants enrolled in the study were included in the analysis except for one participant with missing data.
Median time from the diagnosis of primary melanoma to advanced disease was determined in years.
Outcome measures
| Measure |
Metastatic Melanoma
n=263 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Median Time Since Diagnosis of Melanoma
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1.0 years
Interval 0.1 to 3.3
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SECONDARY outcome
Timeframe: Day 1Population: All participants enrolled in the study were included in the analysis.
Outcome measures
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)
Metastases
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62.9 percentage of participants
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Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)
Primary tumor
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34.1 percentage of participants
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Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)
Relapses
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2.3 percentage of participants
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Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)
Unknown
|
0.8 percentage of participants
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SECONDARY outcome
Timeframe: Day 1Population: All participants enrolled in the study were included in the analysis.
Outcome measures
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other)
Paraffin-embedded blocks
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73.5 percentage of participants
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Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other)
Slides of paraffin blocks
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22.3 percentage of participants
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Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other)
Cytological slides
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3.4 percentage of participants
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Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other)
Other
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0.8 percentage of participants
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SECONDARY outcome
Timeframe: Day 1Population: All participants enrolled in the study were included in the analysis.
Outcome measures
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others)
Other
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5.3 percentage of participants
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Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others)
Buffered formalin
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92.8 percentage of participants
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Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others)
Unknown
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1.9 percentage of participants
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SECONDARY outcome
Timeframe: Day 1Population: All participants enrolled in the study were included in the analysis.
Breslow thickness is defined as the total vertical height of the melanoma, from the very top (called the granular layer) to the area of deepest penetration in the skin. An instrument called an ocular micrometer is used to measure the thickness of the excised (removed) tumor. In general, the higher the Breslow thickness, the worse the prognosis. The classifications were lesser than or equal to (≤) 1.0 millimeters (mm), 1.01 - 2.0 mm, 2.01 - 4.0 mm, greater than (\>) 4.0 mm and Unknown.
Outcome measures
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Percentage of Participants Categorized by Breslow Thickness
1.01 - 2.0 mm
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14.4 percentage of participants
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Percentage of Participants Categorized by Breslow Thickness
2.01 - 4.0 mm
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22.3 percentage of participants
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Percentage of Participants Categorized by Breslow Thickness
>4 mm
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27.3 percentage of participants
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Percentage of Participants Categorized by Breslow Thickness
≤1 mm
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5.7 percentage of participants
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Percentage of Participants Categorized by Breslow Thickness
Unknown
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30.3 percentage of participants
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SECONDARY outcome
Timeframe: Day 1Population: All participants enrolled in the study were included in the analysis
Outcome measures
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Percentage of Participants With Ulceration
With ulceration
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41.7 percentage of participants
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Percentage of Participants With Ulceration
Without ulceration
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26.1 percentage of participants
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Percentage of Participants With Ulceration
Unknown
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32.2 percentage of participants
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SECONDARY outcome
Timeframe: Day 1Population: All participants enrolled in the study were included in the analysis.
Regression in melanoma is the replacement of tumor tissue with fibrosis, degenerated melanoma cells, lymphocytic proliferation, and telangiectasia formation.
Outcome measures
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Percentage of Participants With Regression
With regression
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9.5 percentage of participants
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Percentage of Participants With Regression
Without regression
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53.0 percentage of participants
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Percentage of Participants With Regression
Unknown
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37.5 percentage of participants
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SECONDARY outcome
Timeframe: Day 1Population: All participants enrolled in the study were included in the analysis.
Vascular invasion is defined as the appearance of cancer cells in the lymphatic and blood streams.
Outcome measures
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Percentage of Participants With Vascular Invasion
Unknown
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33.0 percentage of participants
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Percentage of Participants With Vascular Invasion
With vascular invasion
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8.3 percentage of participants
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Percentage of Participants With Vascular Invasion
Without vascular invasion
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58.7 percentage of participants
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SECONDARY outcome
Timeframe: Day 1Population: All participants enrolled in the study were included in the analysis.
Outcome measures
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others)
Cobas® BRAF V600 Mutation Test
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93.1 percentage of participants
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Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others)
Other
|
6.8 percentage of participants
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SECONDARY outcome
Timeframe: Day 1Population: All participants enrolled in the study were included in the analysis.
Outcome measures
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others)
Other
|
3.8 percentage of participants
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Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others)
Cobas® 4800 BRAF V600 Mutation Test
|
96.2 percentage of participants
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SECONDARY outcome
Timeframe: Day 1Population: All participants enrolled in the study were included in the analysis.
The samples were classified based on the percentage of tumor cells referred to the technique as follows: \<60 percent (%), 60-80%, \>80% and Unknown.
Outcome measures
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
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|---|---|
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Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique
<60%
|
12.1 percentage of participants
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Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique
60-80%
|
31.4 percentage of participants
|
|
Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique
>80%
|
33.0 percentage of participants
|
|
Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique
Unknown
|
23.5 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1Population: All participants enrolled in the study were included in the analysis.
Outcome measures
| Measure |
Metastatic Melanoma
n=264 Participants
Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
|
|---|---|
|
Percentage of Participants With Adequate Quality/Quantity of Tumor Sample
|
100.0 percentage of participants
|
Adverse Events
Metastatic Melanoma
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER