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PDL1 in Ovarian High Grade Serous Carcinoma

Prognostic Value of PDL1 in Ovarian High Grade Serous Carcinoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04507191
Enrollment
54
Registered
2020-08-11
Start date
2012-12-01
Completion date
2019-12-30
Last updated
2020-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Brief summary

the main purpose is to study the prognostic effect of PDL1 in ovarian cancer especially HGSC. Therefore, in the present study the investigators analyzed the expression of PDL1in HGSC by immunohistochemistry, and results were correlated to prognosis.

Detailed description

this cross-sectional study on 54 specimens of primary ovarian high grade serous carcinoma cases who attended to Oncology Centre, Mansoura University, Mansoura, Egypt in the period from 2012 till 2019. The cases were chosen randomly. All clinicopathological data including tumor stage (T), L.N metastases (N), metastasis (M), (FIGO) staging system, ascites, recurrence, residual tumor, CEA level, CA125 level, and peritoneal deposits analyzed. The investigator followed the clinical outcomes in the form of disease free survival (DFS) and overall survival (OS). The mean duration of follow up will be 43.4 months. The OS were calculated from the time of diagnosis to death. DFS is the time from the end of therapy to first recurrence or metastases. the specimens were stained with PDL1 marker in pathology department Port Said university. Statistical analysis: Data was analyzed using SPSS software V.16. Continuous data was presented in the form of mean (SD) or Median (min-max) according to the results of Shapiro-Wilk testing for the assumptions of normal distributions of data. Categorical data will be presented in the form of frequencies and percentages. Statistical significance will be tested by Welch's t-test, or Mann-Whitney U for continuous data (with respect to presence or absence of normal distribution of data). Also, chi square test or Fisher's Exact Test will be performed for categorical data (with respect to the minimal expected values in the contingencies tables). Correlations of different tumour markers will be calculated using Spearman's rho Coefficient. Kaplan-Meier test was used to test for overall survival and disease free survival of patients with respect to tumour expression of PDL1. Comparisons will be done using Log Rank (Mantel-Cox). Significance level is set at 0.05.

Interventions

immunohistochemical staining of programmed death-ligand 1 (PDL1) marker

Sponsors

Mansoura University Hospital
CollaboratorOTHER
Port Said University hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* patients diagnosed with primary ovarian cancer

Exclusion criteria

* patients with metastatic ovarian cancer

Design outcomes

Primary

MeasureTime frameDescription
number of slides stained positive to PDL1 marker7 years from 2012 to 2019using immunohistochemical staining for PDL1 markers for all slides of cases with ovarian tumor

Secondary

MeasureTime frameDescription
correlation between PDL1 expression to clinicopathological parameters of ovarian high grade serous carcinoma7 years from 2012 to 2019correlation between PDL1 expression to criteria as ascites, peritoneal nodules and metastasis

Other

MeasureTime frameDescription
correlation between PDL1 expression to prognosis of ovarian high grade serous carcinoma43.3 monthscorrelation between PDL1 expression to cancer free peroid

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026