Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03387020 · OUTCOME

Percent Change in ki67 Between Archival and Post-treatment Tissue

Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors · Source last updated 2021-08-27

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

Measure
MEDIAN
Unit
Change of Percentage of Ki67 in Tumor
Interval / dispersion
Full Range
Time frame
Up to 2 years

What was measured

For the surgical study, Ki67 will be evaluated in paired pre-treatment tumor (diagnostic) and post-treatment tumor (recurrent) tissue in consenting patients to assess percent change. The percent of Ki67 in tumor tissues will be measured and the result is presented as the percent of Ki67 in post-treatment tumor minus the percent of Ki67 measured in pre-treatment tumor.

Analysis population: Consented patients in surgical study with pre-treatment tumor and post-treatment tumor tissue available

Groups in this outcome

Surgical

Patients who are undergoing surgery also receive ribociclib PO QD on days 7-10 at 120 mg/m2/day before surgery

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

Analysis denominator · Participants

GroupSource count
Surgical2

Reported measurements

Source class 1
Values in Change of Percentage of Ki67 in Tumor · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Surgical-20Not reported-35-5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -35
        upper Limit
        -5
        value
        -20
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
For the surgical study, Ki67 will be evaluated in paired pre-treatment tumor (diagnostic) and post-treatment tumor (recurrent) tissue in consenting patients to assess percent change. The percent of Ki67 in tumor tissues will be measured and the result is presented as the percent of Ki67 in post-treatment tumor minus the percent of Ki67 measured in pre-treatment tumor.
dispersion Type
Full Range
groups
  1. description
    Patients who are undergoing surgery also receive ribociclib PO QD on days 7-10 at 120 mg/m2/day before surgery
    id
    OG000
    title
    Surgical
param Type
MEDIAN
population Description
Consented patients in surgical study with pre-treatment tumor and post-treatment tumor tissue available
reporting Status
POSTED
time Frame
Up to 2 years
title
Percent Change in ki67 Between Archival and Post-treatment Tissue
type
SECONDARY
unit Of Measure
Change of Percentage of Ki67 in Tumor

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

Preserved source evidence · Not medical advice