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NCT04283773 · OUTCOME

Measurement of Ki67 Expression in Malignant Ovarian Germ Cell Tumors.

Immunohistochemical Evaluation of Protein P16 Expression in Ovarian Germ Cell Tumors. · Source last updated 2021-09-08

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

Measure
MEDIAN
Unit
percentage of Ki67 positive nuclear cell
Interval / dispersion
Full Range
Time frame
Antibody exposure 2 hrs , assessed up to 1 day for each run of sections assessed.

What was measured

For KI67 IHC staining for malignant cases, percentage of nuclear positivity stained cells were assessed, regardless intensity of staining in all sections examined (at least 1000 tumor cells were counted per section for estimation of KI index).Correlation analysis was used to test the association between Ki-67 and other variables (Spearman' Ranked correlation). A p-value \< 0.05 was considered significant.

Analysis population: Measurement of Ki67 expression in malignant ovarian germ cell tumors only. That explains why analysis obtained on Arm/Group 1 ( MOGCTs) only.

Groups in this outcome

Measurement of Ki67 Expression in Malignant Ovarian Germ Cell Tumors.

22 cases of malignant ovarian germ cell tumors ; 5cases of dysgerminoma ( one of them is bilateral) , 9 cases of yolk sac tumor and 8 cases of immature teratoma. For KI67 IHC staining for malignant cases, percentage of nuclear positivity stained cells were assessed. KI67 LI is estimated by percentage of positive nuclei to all tumor cells from 0 to 100% scale.

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

Analysis denominator · Participants

GroupSource count
Measurement of Ki67 Expression in Malignant Ovarian Germ Cell Tumors.22

Reported measurements

Source class 1
Values in percentage of Ki67 positive nuclear cell · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Measurement of Ki67 Expression in Malignant Ovarian Germ Cell Tumors.15Not reported0100Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8
    group Description
    Correlation between Ki 67 expression using percentage of Ki67 positive nuclei and P16 cytoplasmic expression using German semi quantitative score among MOGCT group. Data were analysed using IBM-SPSS version 24. Correlation analysis was used (Spearman' Ranked correlation, 2-tailed). A p-value \< 0.05 was considered significant.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.009
    p Value Comment
    Data were analysed using IBM-SPSS version 24. Correlation analysis was used (Spearman' Ranked correlation, 2-tailed). A p-value \< 0.05 was considered significant.
    param Type
    Hazard Ratio, log
    param Value
    0.009
    statistical Method
    Spearman's rank correlation coefficient(
Complete source fields
analyses
  1. ci Lower Limit
    0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8
    group Description
    Correlation between Ki 67 expression using percentage of Ki67 positive nuclei and P16 cytoplasmic expression using German semi quantitative score among MOGCT group. Data were analysed using IBM-SPSS version 24. Correlation analysis was used (Spearman' Ranked correlation, 2-tailed). A p-value \< 0.05 was considered significant.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.009
    p Value Comment
    Data were analysed using IBM-SPSS version 24. Correlation analysis was used (Spearman' Ranked correlation, 2-tailed). A p-value \< 0.05 was considered significant.
    param Type
    Hazard Ratio, log
    param Value
    0.009
    statistical Method
    Spearman's rank correlation coefficient(
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        100
        value
        15
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    units
    Participants
description
For KI67 IHC staining for malignant cases, percentage of nuclear positivity stained cells were assessed, regardless intensity of staining in all sections examined (at least 1000 tumor cells were counted per section for estimation of KI index).Correlation analysis was used to test the association between Ki-67 and other variables (Spearman' Ranked correlation). A p-value \< 0.05 was considered significant.
dispersion Type
Full Range
groups
  1. description
    22 cases of malignant ovarian germ cell tumors ; 5cases of dysgerminoma ( one of them is bilateral) , 9 cases of yolk sac tumor and 8 cases of immature teratoma. For KI67 IHC staining for malignant cases, percentage of nuclear positivity stained cells were assessed. KI67 LI is estimated by percentage of positive nuclei to all tumor cells from 0 to 100% scale.
    id
    OG000
    title
    Measurement of Ki67 Expression in Malignant Ovarian Germ Cell Tumors.
param Type
MEDIAN
population Description
Measurement of Ki67 expression in malignant ovarian germ cell tumors only. That explains why analysis obtained on Arm/Group 1 ( MOGCTs) only.
reporting Status
POSTED
time Frame
Antibody exposure 2 hrs , assessed up to 1 day for each run of sections assessed.
title
Measurement of Ki67 Expression in Malignant Ovarian Germ Cell Tumors.
type
PRIMARY
unit Of Measure
percentage of Ki67 positive nuclear cell

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

Preserved source evidence · Not medical advice