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NCT02762877 · OUTCOME

Concordance of Genomic Alterations in ALK (EML4-ALK Fusions) Detected in Plasma Versus Tumor Tissue.

Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma in Non Small Cell Lung Cancer · Source last updated 2020-11-17

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

Measure
NUMBER
Unit
Overall percent agreement (OPA)
Interval / dispersion
95% Confidence Interval
Time frame
Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks

What was measured

Assess concordance of genomic alterations in ALK (EML4-ALK fusions) detected in plasma (using the OncotypeSEQ Liquid Select assay) versus tumor tissue (assessed centrally using FoundationOne OR locally based on the patient's clinic) in stage IV non squamous NSCLC patients who are newly diagnosed or progressing on treatment.

Analysis population: Subjects who received ALK (EML4-ALK fusion) mutation testing on both their tissue and plasma samples.

Groups in this outcome

Patients With Non-squamous NSCLC Either Newly Diagnosed or Pro

Patients with non-squamous NSCLC either newly diagnosed or progressing on any therapy (except erlotinib, gefitinib, or afatinib).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Patients With Non-squamous NSCLC Either Newly Diagnosed or Pro115

Reported measurements

Source class 1
Values in Overall percent agreement (OPA) · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Patients With Non-squamous NSCLC Either Newly Diagnosed or Pro95.7Not reported90.198.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        90.1
        upper Limit
        98.6
        value
        95.7
denoms
  1. counts
    1. group Id
      OG000
      value
      115
    units
    Participants
description
Assess concordance of genomic alterations in ALK (EML4-ALK fusions) detected in plasma (using the OncotypeSEQ Liquid Select assay) versus tumor tissue (assessed centrally using FoundationOne OR locally based on the patient's clinic) in stage IV non squamous NSCLC patients who are newly diagnosed or progressing on treatment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with non-squamous NSCLC either newly diagnosed or progressing on any therapy (except erlotinib, gefitinib, or afatinib).
    id
    OG000
    title
    Patients With Non-squamous NSCLC Either Newly Diagnosed or Pro
param Type
NUMBER
population Description
Subjects who received ALK (EML4-ALK fusion) mutation testing on both their tissue and plasma samples.
reporting Status
POSTED
time Frame
Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks
title
Concordance of Genomic Alterations in ALK (EML4-ALK Fusions) Detected in Plasma Versus Tumor Tissue.
type
SECONDARY
unit Of Measure
Overall percent agreement (OPA)

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

Preserved source evidence · Not medical advice