Epithelial High Grade Serous Ovarian CancerNCT07528911
Elements of Adaptive Immunity in Epithelial Ovarian Cancer
An observational study of Epithelial High Grade Serous Ovarian Cancer, run by Hellenic Cooperative Oncology Group at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Epithelial High Grade Serous Ovarian Cancer
- What is being tested?
- Assessment of elements of adaptive immunity in tumor biopsies
- How many people
- 687 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2023to 22 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: -Patients with advanced high grade serous ovarian cancer treated with carboplatin/paclitaxel chemotherapy
Who may be able to join
- Patients with advanced high grade serous ovarian cancer treated with carboplatin/paclitaxel chemotherapy
Who cannot join
- Any other histology than high grade ovarian cancer
- Patients with stages I-II (based on FIGO staging)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Assessment of elements of adaptive immunity in tumor biopsies
- Keywords
- immune microenvironment, CD8+ T cells, plasma cells, Tertiary lymphoid structures
- Medical subject headings
- Tertiary Lymphoid Structures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with high grade serous ovarian cancer treated with chemotherapy | Not described Receives: Other: Assessment of elements of adaptive immunity in tumor biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of: Tertiary Lymphoid Structures (presence, absence) in tumor biopsies
Measured: through study completion, an average of 3 years
Secondary outcomes (4)
Plasma cells (4-tiered score)
Measured: 3- years time frame (upon study completion)
PD-L1 score (TPS score) in tumor biopsies
Measured: upon study completion (3 years)
CD8 cells (low : <5 cells/HPF vs high (> 5 cells/HPF) expression) in tumor biopsies
Measured: upron study completion (3 years)
p53 (presence, absence) in tumor biopsies (immunohistochemistry)
Measured: upon study compeltion (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Apr 2023
- Primary completion1 Apr 2025
- Study completion22 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial High Grade Serous Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 687 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Attikon Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528911
- Sponsor's protocol ID
- TR_4G/23
- Status last verified
- Apr 2026
- First submitted
- 23 Jul 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Significance of Adaptive Immunity Cell Infiltrates in the Microenvironment of High-grade Serous Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07528911
- Acronym / sponsor ID
- TR_4G/23
- Keywords
- immune microenvironment, CD8+ T cells, plasma cells, Tertiary lymphoid structures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 687 participants (actual)
- Lead sponsor
- Hellenic Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- Attikon Hospital
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 22 Jun 2025 (actual)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with high grade serous ovarian cancer treated with chemotherapy | – | Other: Assessment of elements of adaptive immunity in tumor biopsies |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- -Patients with advanced high grade serous ovarian cancer treated with carboplatin/paclitaxel chemotherapy
Key inclusion criteria (1 listed)
- Patients with advanced high grade serous ovarian cancer treated with carboplatin/paclitaxel chemotherapy
Key exclusion criteria (2 listed)
- Any other histology than high grade ovarian cancer
- Patients with stages I-II (based on FIGO staging)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of elements of adaptive immunity in tumor biopsiesTertiary lymphoid structures, Plasma cells, p53 and CD8+ T cells will be evaluated at tumor biopsies of patients with advanced ovarian cancer treated with chemotherapy. | Other | Patients with high grade serous ovarian cancer treated with chemotherapy |
Primary outcome
Assessment of: Tertiary Lymphoid Structures (presence, absence) in tumor biopsies
Time frame: through study completion, an average of 3 years
4 secondary outcomes
Plasma cells (4-tiered score)
Time frame: 3- years time frame (upon study completion)
PD-L1 score (TPS score) in tumor biopsies
Time frame: 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)
p53 (presence, absence) in tumor biopsies (immunohistochemistry)
Time frame: upon study compeltion (3 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
Related trials for Epithelial High Grade Serous Ovarian Cancer
RecruitingPhase 1/2
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High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Active, not recruiting
68Ga-FAPI PET/CT in the Staging of High-Grade Epithelial Ovarian Cancers: A Pilot Study
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RecruitingPhase 1/2
A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003).
Ovarian Cancer Recurrent
RecruitingPhase 3
A Clinical Trial of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab in Participants With Ovarian Cancer Who Have Progressed During Treatment With PARP-inhibitors Treatment on First Line Maintenance (MK-5909-008/ENGOT-ov107/GOG-3142 / REJOICE-Ovarian05)
Ovarian Cancer, Peritoneal Cancer
Recruiting
OV Precision: Study Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy
Ovarian Neoplasm Epithelial, Fallopian Tube Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epithelial High Grade Serous Ovarian Cancer, run by Hellenic Cooperative Oncology Group at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of: Tertiary Lymphoid Structures (presence, absence) in tumor biopsies (time frame: through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.