PDL1 in Ovarian High Grade Serous Carcinoma

Ovarian Cancer Clinical Trial

Official title:

Prognostic Value of PDL1 in Ovarian High Grade Serous Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04507191
• Other study ID #: R.20.07.957
• Status: Completed
• Start date: December 1, 2012
• Est. completion date: December 30, 2019

Study information

• Verified date: August 2020
• Source: Port Said University hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 30, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• patients diagnosed with primary ovarian cancer

Exclusion Criteria:

• patients with metastatic ovarian cancer

Related Conditions & MeSH terms

• Ovarian Cancer

Intervention

Diagnostic Test:
• immunohistochemical staining
immunohistochemical staining of programmed death-ligand 1 (PDL1) marker

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Port Said University	Port Said

Sponsors (2)

Lead Sponsor	Collaborator
Port Said University hospital	Mansoura University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	correlation between PDL1 expression to prognosis of ovarian high grade serous carcinoma	correlation between PDL1 expression to cancer free peroid	43.3 months
Primary	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	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