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NCT01804140 · OUTCOME

Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples

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
participants
Interval / dispersion
Not reported
Time frame
Up to 1 year

What was measured

FFPEs tumor samples (at least 5 serially-cut, unstained, 5 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. V600E, V600K, V600D, and V600R are the different types of BRAF V600 mutations.

Analysis population: All the participants who were enrolled and were evaluable for the BRAF V600 mutations were included in the analysis.

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

GroupSource count
Participants With Confirmed Solid Tumors or Multiple Myeloma548

Reported measurements

BRAF V600E
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With Confirmed Solid Tumors or Multiple Myeloma16Not reportedNot reportedNot reportedNot reported
BRAF V600K
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With Confirmed Solid Tumors or Multiple Myeloma0Not reportedNot reportedNot reportedNot reported
BRAF V600D
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With Confirmed Solid Tumors or Multiple Myeloma0Not reportedNot reportedNot reportedNot reported
BRAF V600R
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With Confirmed Solid Tumors or Multiple Myeloma0Not reportedNot reportedNot reportedNot reported
Other V600
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With Confirmed Solid Tumors or Multiple Myeloma0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    BRAF V600E
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    BRAF V600K
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    BRAF V600D
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    BRAF V600R
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Other V600
denoms
  1. counts
    1. group Id
      OG000
      value
      548
    units
    Participants
description
FFPEs tumor samples (at least 5 serially-cut, unstained, 5 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. V600E, V600K, V600D, and V600R are the different types of BRAF V600 mutations.
groups
  1. 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.
reporting Status
POSTED
time Frame
Up to 1 year
title
Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples
type
PRIMARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice