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NCT Number: NCT04507191

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients diagnosed with primary ovarian cancer

Exclusion criteria

  • patients with metastatic ovarian cancer

Treatment and study plan

immunohistochemical staining

Diagnostic Test

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

Primary outcomes

  1. number of slides stained positive to PDL1 marker

    Time frame: 7 years from 2012 to 2019

    using immunohistochemical staining for PDL1 markers for all slides of cases with ovarian tumor

Secondary outcomes

  1. correlation between PDL1 expression to clinicopathological parameters of ovarian high grade serous carcinoma

    Time frame: 7 years from 2012 to 2019

    correlation between PDL1 expression to criteria as ascites, peritoneal nodules and metastasis

Other outcomes

  1. correlation between PDL1 expression to prognosis of ovarian high grade serous carcinoma

    Time frame: 43.3 months

    correlation between PDL1 expression to cancer free peroid

Sponsors and collaborators

Lead sponsor

Port Said University hospital

Other

Collaborators

  • Mansoura University Hospital

Registry information

Official study title

Prognostic Value of PDL1 in Ovarian High Grade Serous Carcinoma

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2020
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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