Elements of Adaptive Immunity in Epithelial Ovarian Cancer

April 7, 2026 updated by: Hellenic Cooperative Oncology Group

Prognostic Significance of Adaptive Immunity Cell Infiltrates in the Microenvironment of High-grade Serous Ovarian Cancer.

The study seeks to evaluate the presence and correlation with clinical outcome of several components of adaptive immunity (TILs, TLS, plasma cells and PD-L1 expression) in tumor specimens of patients with EOC treated with carboplatin/paclitaxel chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

687

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • Hellenic Cooperative Oncology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

-Patients with advanced high grade serous ovarian cancer treated with carboplatin/paclitaxel chemotherapy

Description

Inclusion Criteria:

  • Patients with advanced high grade serous ovarian cancer treated with carboplatin/paclitaxel chemotherapy

Exclusion Criteria:

  • Any other histology than high grade ovarian cancer
  • Patients with stages I-II (based on FIGO staging)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with high grade serous ovarian cancer treated with chemotherapy
Other: Assessment of elements of adaptive immunity in tumor biopsies
Tertiary lymphoid structures, Plasma cells, p53 and CD8+ T cells will be evaluated at tumor biopsies of patients with advanced ovarian cancer treated with chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of: Tertiary Lymphoid Structures (presence, absence) in tumor biopsies
Time Frame: through study completion, an average of 3 years
through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma cells (4-tiered score)
Time Frame: 3- years time frame (upon study completion)
3- years time frame (upon study completion)
PD-L1 score (TPS score) in tumor biopsies
Time Frame: upon study completion (3 years)
upon study completion (3 years)
CD8 cells (low : <5 cells/HPF vs high (> 5 cells/HPF) expression) in tumor biopsies
Time Frame: upron study completion (3 years)
upron study completion (3 years)
p53 (presence, absence) in tumor biopsies (immunohistochemistry)
Time Frame: upon study compeltion (3 years)
upon study compeltion (3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Cooperative Oncology Group

Collaborators

Attikon Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

April 1, 2025

Study Completion (Actual)

June 22, 2025

Study Registration Dates

First Submitted

July 23, 2025

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR_4G/23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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