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NCT04283773 · OUTCOME

Correlation Between P16 Cytoplasmic Score and FIGO Staging of MOGCTs.

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
MEAN
Unit
score on a scale
Interval / dispersion
80% Confidence Interval
Time frame
After obtaining of results and collecting raw data , within 2 months.

What was measured

P16 cytoplasmic score is assessed by German quantitative scoring system by multiplying scores of intensity of staining ( 0= No , 1= weak , 2= moderate , 3 = strong ) in scores of intensity of staining ( 0 = less than 10% , 1= 11- 20 % , 2= 21-50 % , 3= 51-80% , 4= more than 80%) to induce final scores range between ( 0, 1,2,4,6,8,9 and 12). FIGO staging system for ovarian tumors between Stage I ( limited to ovaries) , II ( with pelvic extension) , III ( with peritoneal extension) and IV ( distant metastasis) , and it is reported from medical records of patients. One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons . Data was expressed as mean (SD). A p-value \< 0.05 was considered significant.

Analysis population: P16 cytoplasmic score is assessed by German quantitative scoring system by multiplying scores of intensity of staining ( 0= No , 1= weak , 2= moderate , 3 = strong ) in scores of intensity of staining ( 0 = less than 10% , 1= 11- 20 % , 2= 21-50 % , 3= 51-80% , 4= more than 80%) to induce final scores range between ( 0, 1,2,4,6,8,9 and 12). FIGO staging for (malignant ovarian tumors only) is reported from medical records of patients . That explains why this measurement Arm/group 1( MOGCTs)only.

Groups in this outcome

Malignant Ovarian Germ Cell Tumors ( MOGCTs).

22 cases of malignant ovarian germ cell tumors ; include Dysgerminoma , yolk sac tumor and immature teratomas will be treated by anti P16 antibody

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

Analysis denominator · Participants

GroupSource count
Malignant Ovarian Germ Cell Tumors ( MOGCTs).22

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: 80% Confidence Interval
GroupValueSpreadLowerUpperComment
Malignant Ovarian Germ Cell Tumors ( MOGCTs).11Not reported9.513.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    9.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    80
    ci Upper Limit
    13
    dispersion Type
    STANDARD_DEVIATION
    dispersion Value
    1.5
    group Description
    Correlation between P16 cytoplasmic score using German semi-quantitative system and FIGO staging of MOGCTs was done via One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD).
    group Ids
    1. OG000
    non Inferiority Comment
    One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD). P value is significant if less than 0.05.
    non Inferiority Type
    SUPERIORITY
    p Value
    0.699
    p Value Comment
    One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD). P value is significant if less than 0.05.
    param Type
    Mean Difference (Final Values)
    param Value
    11
    statistical Method
    ANOVA
Complete source fields
analyses
  1. ci Lower Limit
    9.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    80
    ci Upper Limit
    13
    dispersion Type
    STANDARD_DEVIATION
    dispersion Value
    1.5
    group Description
    Correlation between P16 cytoplasmic score using German semi-quantitative system and FIGO staging of MOGCTs was done via One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD).
    group Ids
    1. OG000
    non Inferiority Comment
    One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD). P value is significant if less than 0.05.
    non Inferiority Type
    SUPERIORITY
    p Value
    0.699
    p Value Comment
    One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD). P value is significant if less than 0.05.
    param Type
    Mean Difference (Final Values)
    param Value
    11
    statistical Method
    ANOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.5
        upper Limit
        13.5
        value
        11
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    units
    Participants
description
P16 cytoplasmic score is assessed by German quantitative scoring system by multiplying scores of intensity of staining ( 0= No , 1= weak , 2= moderate , 3 = strong ) in scores of intensity of staining ( 0 = less than 10% , 1= 11- 20 % , 2= 21-50 % , 3= 51-80% , 4= more than 80%) to induce final scores range between ( 0, 1,2,4,6,8,9 and 12). FIGO staging system for ovarian tumors between Stage I ( limited to ovaries) , II ( with pelvic extension) , III ( with peritoneal extension) and IV ( distant metastasis) , and it is reported from medical records of patients. One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons . Data was expressed as mean (SD). A p-value \< 0.05 was considered significant.
dispersion Type
80% Confidence Interval
groups
  1. description
    22 cases of malignant ovarian germ cell tumors ; include Dysgerminoma , yolk sac tumor and immature teratomas will be treated by anti P16 antibody
    id
    OG000
    title
    Malignant Ovarian Germ Cell Tumors ( MOGCTs).
param Type
MEAN
population Description
P16 cytoplasmic score is assessed by German quantitative scoring system by multiplying scores of intensity of staining ( 0= No , 1= weak , 2= moderate , 3 = strong ) in scores of intensity of staining ( 0 = less than 10% , 1= 11- 20 % , 2= 21-50 % , 3= 51-80% , 4= more than 80%) to induce final scores range between ( 0, 1,2,4,6,8,9 and 12). FIGO staging for (malignant ovarian tumors only) is reported from medical records of patients . That explains why this measurement Arm/group 1( MOGCTs)only.
reporting Status
POSTED
time Frame
After obtaining of results and collecting raw data , within 2 months.
title
Correlation Between P16 Cytoplasmic Score and FIGO Staging of MOGCTs.
type
SECONDARY
unit Of Measure
score on a scale

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Preserved source evidence · Not medical advice