NCT01804140 · OUTCOME
Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type
A Screening Study to Detect BRAF V600 Mutation-Positive Patients For Enrollment Into Clinical Research Studies of Zelboraf (Vemurafenib) · Source last updated 2016-11-02
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 1 year
What was measured
Formalin-fixed paraffin-embedded (FFPEs) tumor samples (at least 5 serially-cut, unstained, 5 micrometer \[μm\] sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure.
Analysis population: All the participants who were enrolled and were evaluable for the BRAF V600 mutations were included in the analysis. n is the number of participants with that type of cancer in the total population.
Groups in this outcome
Participants With Confirmed Solid Tumors or Multiple Myeloma
Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Participants With Confirmed Solid Tumors or Multiple Myeloma | 548 |
|---|
Reported measurements
Breast cancer (n=85)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Participants With Confirmed Solid Tumors or Multiple Myeloma | 0 | Not reported | 0 | 0 | Not reported |
|---|
Non-small cell lung carcinoma (n=65)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Participants With Confirmed Solid Tumors or Multiple Myeloma | 3 | Not reported | 0.4 | 10.7 | Not reported |
|---|
Colorectal cancer (n=74)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Participants With Confirmed Solid Tumors or Multiple Myeloma | 11 | Not reported | 4.8 | 20.2 | Not reported |
|---|
Ovarian cancer (n=66)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Participants With Confirmed Solid Tumors or Multiple Myeloma | 0 | Not reported | 0 | 0 | Not reported |
|---|
Prostate cancer (n=21)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Participants With Confirmed Solid Tumors or Multiple Myeloma | 0 | Not reported | 0 | 0 | Not reported |
|---|
Multiple myeloma (n=31)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Participants With Confirmed Solid Tumors or Multiple Myeloma | 3 | Not reported | 0.1 | 16.7 | Not reported |
|---|
Biliary tract cancer (n=16)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Participants With Confirmed Solid Tumors or Multiple Myeloma | 6 | Not reported | 0.2 | 30.2 | Not reported |
|---|
Other cancer (n=190)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Participants With Confirmed Solid Tumors or Multiple Myeloma | 2 | Not reported | 0.6 | 5.3 | Not reported |
|---|
Overall (n=540)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Participants With Confirmed Solid Tumors or Multiple Myeloma | 3 | Not reported | 1.7 | 4.7 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- title
- Breast cancer (n=85)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.4
- upper Limit
- 10.7
- value
- 3
- title
- Non-small cell lung carcinoma (n=65)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.8
- upper Limit
- 20.2
- value
- 11
- title
- Colorectal cancer (n=74)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- title
- Ovarian cancer (n=66)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- title
- Prostate cancer (n=21)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.1
- upper Limit
- 16.7
- value
- 3
- title
- Multiple myeloma (n=31)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.2
- upper Limit
- 30.2
- value
- 6
- title
- Biliary tract cancer (n=16)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.6
- upper Limit
- 5.3
- value
- 2
- title
- Other cancer (n=190)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.7
- upper Limit
- 4.7
- value
- 3
- title
- Overall (n=540)
- description
- Formalin-fixed paraffin-embedded (FFPEs) tumor samples (at least 5 serially-cut, unstained, 5 micrometer \[μm\] sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
- id
- OG000
- title
- Participants With Confirmed Solid Tumors or Multiple Myeloma
- param Type
- NUMBER
- population Description
- All the participants who were enrolled and were evaluable for the BRAF V600 mutations were included in the analysis. n is the number of participants with that type of cancer in the total population.
- reporting Status
- POSTED
- time Frame
- Up to 1 year
- title
- Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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