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NCT01182350 · OUTCOME

Feasibility Rate of Molecular Approach to Therapy

Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG) · Source last updated 2019-09-04

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
90% Confidence Interval
Time frame
3 weeks

What was measured

Feasibility rate of the molecular strategy is based on the percentage of participants either with inadequate tissue from surgical biopsy to confirm DIPG diagnosis and/or with uninterpretable results for identification of EGFR overexpression and MGMT methylation status.

Analysis population: The analysis dataset is comprised of all enrolled participants who underwent stereotactic biopsy.

Groups in this outcome

All Biopsied Participants

Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Treatment directed based on tumor biopsy results requires classification of patients into 1 of 4 potential cohorts: O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status (negative versus positive) and epidermal growth factor receptor (EGFR) overexpression status (negative versus positive).

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

Analysis denominator · Participants

GroupSource count
All Biopsied Participants50

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
All Biopsied Participants92.0Not reported82.697.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        82.6
        upper Limit
        97.2
        value
        92.0
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    units
    Participants
description
Feasibility rate of the molecular strategy is based on the percentage of participants either with inadequate tissue from surgical biopsy to confirm DIPG diagnosis and/or with uninterpretable results for identification of EGFR overexpression and MGMT methylation status.
dispersion Type
90% Confidence Interval
groups
  1. description
    Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Treatment directed based on tumor biopsy results requires classification of patients into 1 of 4 potential cohorts: O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status (negative versus positive) and epidermal growth factor receptor (EGFR) overexpression status (negative versus positive).
    id
    OG000
    title
    All Biopsied Participants
param Type
NUMBER
population Description
The analysis dataset is comprised of all enrolled participants who underwent stereotactic biopsy.
reporting Status
POSTED
time Frame
3 weeks
title
Feasibility Rate of Molecular Approach to Therapy
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice