TriangleNCT04283773 · STUDY IN CONTEXT
Immunohistochemical Evaluation of Protein P16 Expression in Ovarian Germ Cell Tumors.
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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).
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-germ-cell-tumor
- nct id
- NCT04283773
- trial label
- Immunohistochemical Evaluation of Protein P16 Expression in Ovarian Germ Cell Tumors.
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 3
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-germ-cell-tumor
- nct id
- NCT04283773
- outcome key
- om-0000
- source section id
- NCT04283773-om-0000
- source outcome index
- 0
- endpoint
- P16 Evaluation in Ovarian Germ Cell Tumors
- endpoint definition
- 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).
- time origin
- Antibody exposure overnight, assessed up to 3 days for each run of sections assessed.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-germ-cell-tumor
- nct id
- NCT04283773
- outcome key
- om-0001
- source section id
- NCT04283773-om-0001
- source outcome index
- 1
- endpoint
- Measurement of Ki67 Expression in Malignant Ovarian Germ Cell Tumors.
- endpoint definition
- 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.
- time origin
- Antibody exposure 2 hrs , assessed up to 1 day for each run of sections assessed.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Measurement of Ki67 expression in malignant ovarian germ cell tumors only. That explains why analysis obtained on Arm/Group 1 ( MOGCTs) only.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-germ-cell-tumor
- nct id
- NCT04283773
- outcome key
- om-0002
- source section id
- NCT04283773-om-0002
- source outcome index
- 2
- endpoint
- Correlation Between P16 Cytoplasmic Score and FIGO Staging of MOGCTs.
- endpoint definition
- 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.
- time origin
- After obtaining of results and collecting raw data , within 2 months.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-germ-cell-tumor
- nct id
- NCT04283773
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Malignant Ovarian Germ Cell Tumors ( MOGCTs).
- regimen
- 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.
- analyzed count
- 22
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04283773-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-germ-cell-tumor
- nct id
- NCT04283773
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Mature Cystic Teratomas.
- regimen
- 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.
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04283773-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-germ-cell-tumor
- nct id
- NCT04283773
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Normally Apparent Ovaries.
- regimen
- 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.
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04283773-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-germ-cell-tumor
- nct id
- NCT04283773
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Measurement of Ki67 Expression in Malignant Ovarian Germ Cell Tumors.
- regimen
- 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.
- analyzed count
- 22
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04283773-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-germ-cell-tumor
- nct id
- NCT04283773
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Malignant Ovarian Germ Cell Tumors ( MOGCTs).
- regimen
- 22 cases of malignant ovarian germ cell tumors ; include Dysgerminoma , yolk sac tumor and immature teratomas will be treated by anti P16 antibody
- analyzed count
- 22
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04283773-om-0002#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-germ-cell-tumor
- nct id
- NCT04283773
- harm key
- EG000
- source section id
- NCT04283773-ae
- event group key
- EG000
- event group label
- Immunohistochemical Expression of P16 Expression in Malignant Ovarian Germ Cell Tumors.
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- 1 year
- event definition
- Nature of specimen is paraffin embedded tissue blocks , therefore there is no mortality , harm or serious Adverse Events were obtained to the participants. This explained why "0" is a total number of Participants at Risk.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-germ-cell-tumor
- nct id
- NCT04283773
- harm key
- EG001
- source section id
- NCT04283773-ae
- event group key
- EG001
- event group label
- Immunohistochemical Expression of P16 Expression in Benign Ovarian Germ Cell (MCTs)
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- 1 year
- event definition
- Nature of specimen is paraffin embedded tissue blocks , therefore there is no mortality , harm or serious Adverse Events were obtained to the participants. This explained why "0" is a total number of Participants at Risk.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-germ-cell-tumor
- nct id
- NCT04283773
- harm key
- EG002
- source section id
- NCT04283773-ae
- event group key
- EG002
- event group label
- Immunohistochemical Expression of P16 Expression in Normal Ovarian Tissues.
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- 1 year
- event definition
- Nature of specimen is paraffin embedded tissue blocks , therefore there is no mortality , harm or serious Adverse Events were obtained to the participants. This explained why "0" is a total number of Participants at Risk.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice