NCT01227889 · OUTCOME

Agreement Rate for V600E Mutation Validation of the BRAF Mutation Assay

A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma · Source last updated 2017-10-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Percent agreement
Interval / dispersion: 95% Confidence Interval
Time frame: Screening

What was measured

Analytical and clinical validation of the companion diagnostic (cDx) assay was performed to determine the extent of agreement between the bioMerieux cDx assay (THxID BRAF Assay) and the Clinical Trial Assay (CTA) to detect BRAF mutations to determine participant eligibility into the study. Skin tissue samples collected at the Screening visit were used for this analysis. Multiple specimen per participant were analyzed.

Analysis population: V600E positive participants screened for BREAK-3 study

Groups in this outcome

All Screened Participants

Specimens were tested for V600E mutations to determine trial eligibility with the CTA were retested with the THxID BRAF test. The analytical agreement between the THxID BRAF and the CTA was evaluated for both mutation positive and mutation negative specimens from all sites.

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
All Screened Participants	734

Reported measurements

Agreement for V600E

Values in Percent agreement · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
All Screened Participants	96.70	Not reported	93.6	98.3	Not reported

Agreement for V600K

Values in Percent agreement · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
All Screened Participants	90.00	Not reported	78.6	95.7	Not reported

Agreement for mutation negative

Values in Percent agreement · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
All Screened Participants	95.00	Not reported	91.6	97.0	Not reported

Agreement for overall

Values in Percent agreement · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
All Screened Participants	94.90	Not reported	92.7	96.4	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
93.6
upper Limit
98.3
value
96.70
title
Agreement for V600E
categories
measurements
group Id
OG000
lower Limit
78.6
upper Limit
95.7
value
90.00
title
Agreement for V600K
categories
measurements
group Id
OG000
lower Limit
91.6
upper Limit
97.0
value
95.00
title
Agreement for mutation negative
categories
measurements
group Id
OG000
lower Limit
92.7
upper Limit
96.4
value
94.90
title
Agreement for overall

denoms

counts
group Id
OG000
value
734
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Specimens were tested for V600E mutations to determine trial eligibility with the CTA were retested with the THxID BRAF test. The analytical agreement between the THxID BRAF and the CTA was evaluated for both mutation positive and mutation negative specimens from all sites.
id
OG000
title
All Screened Participants

param Type

NUMBER

population Description

V600E positive participants screened for BREAK-3 study

reporting Status

POSTED

time Frame

Screening

title

Agreement Rate for V600E Mutation Validation of the BRAF Mutation Assay

type

SECONDARY

unit Of Measure

Percent agreement

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice