TriangleNCT04283773 · OUTCOME
P16 Evaluation in Ovarian Germ Cell Tumors
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- units on a scale
- Interval / dispersion
- Full Range
- Time frame
- Antibody exposure overnight, assessed up to 3 days for each run of sections assessed.
What was measured
For P16 IHC staining, the percentage of P16 positive cells and the location of positive signals (nuclear or cytoplasmic) were visually estimated for neoplastic components of all lesions. German Semi-quantitative scoring system were used to evaluate P16 expression as every tumor will be given a score according to the intensity of the cytoplasmic and nucleic staining (no staining = 0, weak staining = 1, moderate staining = 2, strong staining = 3) And the extent of stained cells (0% = 0, 1-10% = 1, 11-50% =2, 51-80% = 3, 81-100% = 4). The final immunoreactive score will be determined by multiplying the intensity scores with the extent of positivity scores of stained cells, with the minimum score of 0 and a maximum score of 12 ( score 0, 1,2,3,4,6,8,9 and 12).
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 and Ki67 antibody. p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267): Treatment of slides that cut from paraffin embedded blocks related to groups by immunohistochemical method by p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267).Additional step for malignant cases , sections were treated by Ki67 antibody.
Mature Cystic Teratomas.
20 cases of mature teratomas will be treated by anti P16 antibody . p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267): Treatment of slides that cut from paraffin embedded blocks related to groups by immunohistochemical method by p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267).Additional step for malignant cases , sections were treated by Ki67 antibody.
Normally Apparent Ovaries.
20 cases of normally apparent ovaries will be treated by anti P16 antibody . p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267): Treatment of slides that cut from paraffin embedded blocks related to groups by immunohistochemical method by p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267).Additional step for malignant cases , sections were treated by Ki67 antibody.
| Group | Source count |
|---|---|
| Malignant Ovarian Germ Cell Tumors ( MOGCTs). | 22 |
| Mature Cystic Teratomas. | 20 |
| Normally Apparent Ovaries. | 20 |
Reported measurements
P16 cytoplasmic expression
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Malignant Ovarian Germ Cell Tumors ( MOGCTs). | 7 | Not reported | 0 | 8 | Not reported |
| Mature Cystic Teratomas. | 4 | Not reported | 0 | 6 | Not reported |
| Normally Apparent Ovaries. | 0 | Not reported | 0 | 4 | Not reported |
P16 nuclear expression
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Malignant Ovarian Germ Cell Tumors ( MOGCTs). | 6 | Not reported | 0 | 8 | Not reported |
| Mature Cystic Teratomas. | 4 | Not reported | 0 | 5 | Not reported |
| Normally Apparent Ovaries. | 0 | Not reported | 0 | 3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 8
- dispersion Type
- STANDARD_DEVIATION
- dispersion Value
- 1.5
- group Description
- Assessment of statistical differences in P16 expression between 3 groups. The immunohistochemical evaluation is done using German- semiquantitative scoring system. The score ranges from ( 0, 1,2,3,4,6,8,9 and 12). The data will entered on SPSS,version 24 as numbers. The test of significance is Kruskal Wallis was used to examine the Difference in Median between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons . A p-value \< 0.05 was considered significant.
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.001
- p Value Comment
- The test of significance is Kruskal Wallis was used to examine the Difference in Median between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons . A p-value \< 0.05 was considered significant.
- param Type
- Median Difference (Final Values)
- param Value
- 0.001
- statistical Method
- Kruskal-Wallis
Complete source fields
- analyses
- ci Lower Limit
- 0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 8
- dispersion Type
- STANDARD_DEVIATION
- dispersion Value
- 1.5
- group Description
- Assessment of statistical differences in P16 expression between 3 groups. The immunohistochemical evaluation is done using German- semiquantitative scoring system. The score ranges from ( 0, 1,2,3,4,6,8,9 and 12). The data will entered on SPSS,version 24 as numbers. The test of significance is Kruskal Wallis was used to examine the Difference in Median between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons . A p-value \< 0.05 was considered significant.
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.001
- p Value Comment
- The test of significance is Kruskal Wallis was used to examine the Difference in Median between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons . A p-value \< 0.05 was considered significant.
- param Type
- Median Difference (Final Values)
- param Value
- 0.001
- statistical Method
- Kruskal-Wallis
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 8
- value
- 7
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 6
- value
- 4
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 4
- value
- 0
- title
- P16 cytoplasmic expression
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 8
- value
- 6
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 5
- value
- 4
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 3
- value
- 0
- title
- P16 nuclear expression
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 20
- units
- Participants
- description
- For P16 IHC staining, the percentage of P16 positive cells and the location of positive signals (nuclear or cytoplasmic) were visually estimated for neoplastic components of all lesions. German Semi-quantitative scoring system were used to evaluate P16 expression as every tumor will be given a score according to the intensity of the cytoplasmic and nucleic staining (no staining = 0, weak staining = 1, moderate staining = 2, strong staining = 3) And the extent of stained cells (0% = 0, 1-10% = 1, 11-50% =2, 51-80% = 3, 81-100% = 4). The final immunoreactive score will be determined by multiplying the intensity scores with the extent of positivity scores of stained cells, with the minimum score of 0 and a maximum score of 12 ( score 0, 1,2,3,4,6,8,9 and 12).
- dispersion Type
- Full Range
- groups
- description
- 22 cases of malignant ovarian germ cell tumors ; include Dysgerminoma , yolk sac tumor and immature teratomas will be treated by anti P16 antibody and Ki67 antibody. p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267): Treatment of slides that cut from paraffin embedded blocks related to groups by immunohistochemical method by p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267).Additional step for malignant cases , sections were treated by Ki67 antibody.
- id
- OG000
- title
- Malignant Ovarian Germ Cell Tumors ( MOGCTs).
- description
- 20 cases of mature teratomas will be treated by anti P16 antibody . p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267): Treatment of slides that cut from paraffin embedded blocks related to groups by immunohistochemical method by p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267).Additional step for malignant cases , sections were treated by Ki67 antibody.
- id
- OG001
- title
- Mature Cystic Teratomas.
- description
- 20 cases of normally apparent ovaries will be treated by anti P16 antibody . p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267): Treatment of slides that cut from paraffin embedded blocks related to groups by immunohistochemical method by p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267).Additional step for malignant cases , sections were treated by Ki67 antibody.
- id
- OG002
- title
- Normally Apparent Ovaries.
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Antibody exposure overnight, assessed up to 3 days for each run of sections assessed.
- title
- P16 Evaluation in Ovarian Germ Cell Tumors
- type
- PRIMARY
- unit Of Measure
- units on a scale
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