PDL1 in Ovarian High Grade Serous Carcinoma

Prognostic Value of PDL1 in Ovarian High Grade Serous Carcinoma

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer
• Intervention / Treatment: Diagnostic test: immunohistochemical staining

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.

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• Egypt
  • Port Said, Egypt, 42511
    • Faculty of Medicine, Port Said University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

all patients diagnosed with primary serous ovarian cancer and subjected to staging laparotomy

Description

Inclusion Criteria:

• patients diagnosed with primary ovarian cancer

Exclusion Criteria:

• patients with metastatic ovarian cancer

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of slides stained positive to PDL1 marker	using immunohistochemical staining for PDL1 markers for all slides of cases with ovarian tumor	7 years from 2012 to 2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between PDL1 expression to clinicopathological parameters of ovarian high grade serous carcinoma	correlation between PDL1 expression to criteria as ascites, peritoneal nodules and metastasis	7 years from 2012 to 2019

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between PDL1 expression to prognosis of ovarian high grade serous carcinoma	correlation between PDL1 expression to cancer free peroid	43.3 months

Collaborators and Investigators

• Sponsor: Port Said University hospital
• Collaborators: Mansoura University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cystadenocarcinoma; Neoplasms, Cystic, Mucinous, and Serous; Cystadenocarcinoma, Serous
• Other Study ID Numbers: R.20.07.957

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No