NCT07528911

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
687

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
9 months until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

July 23, 2025

Last Update Submit

April 7, 2026

Conditions

Epithelial High Grade Serous Ovarian Cancer

Keywords

immune microenvironmentCD8+ T cellsplasma cellsTertiary lymphoid structures

Outcome Measures

Primary Outcomes (1)

  • Assessment of: Tertiary Lymphoid Structures (presence, absence) in tumor biopsies

    through study completion, an average of 3 years

Secondary Outcomes (4)

  • Plasma cells (4-tiered score)

    3- years time frame (upon study completion)

  • PD-L1 score (TPS score) in tumor biopsies

    upon study completion (3 years)

  • CD8 cells (low : <5 cells/HPF vs high (> 5 cells/HPF) expression) in tumor biopsies

    upron study completion (3 years)

  • p53 (presence, absence) in tumor biopsies (immunohistochemistry)

    upon study compeltion (3 years)

Study Arms (1)

Patients with high grade serous ovarian cancer treated with chemotherapy

Other: Assessment of elements of adaptive immunity in tumor biopsies

Interventions

Assessment of elements of adaptive immunity in tumor biopsiesOTHER

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.

Patients with high grade serous ovarian cancer treated with chemotherapy

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hellenic Cooperative Oncology Group

Athens, Greece

Location

MeSH Terms

Conditions

Tertiary Lymphoid Structures

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2025

First Posted

April 14, 2026

Study Start

April 1, 2023

Primary Completion

April 1, 2025

Study Completion

June 22, 2025

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

GR(1)