ClinicalTrials.gg
RecruitingNCT05984875IOSI-GYNE-001Updated Nov 18, 2025

The Immune Landscape of Epithelial Ovarian Cancer

An observational study in Epithelial Ovarian Cancer, sponsored by Oncology Institute of Southern Switzerland. Recruiting at 1 site in Switzerland. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by Oncology Institute of Southern Switzerland · Observational

From the registry’s dates

  • Started Dec 2022; still recruiting 3 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
74
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 18 studies in Carcinoma, Ovarian Epithelial with a site in Switzerland — 2 open to participants now, 5 under way, 1 of them phase 3. Carcinoma, Ovarian Epithelial · Switzerland.

Started
2022
with 2 others
Observational
2 of 18
1 open now
Registered
17th of 18
by date
Lead sponsor
2 of 18
Oncology Institute of Southern Switzerland

Among the 18 studies in Carcinoma, Ovarian Epithelial with a site in Switzerland, this one is one of 3 that started in 2022, is one of 2 observational ones, and was the 17th registered.

Carcinoma, Ovarian Epithelial

798 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 102 are open to participants now.

Browse Carcinoma, Ovarian Epithelial studies →

Open to participants now

2 of the 18 studies in Carcinoma, Ovarian Epithelial with a site in Switzerland are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 75 Carcinoma, Ovarian Epithelial studies recruiting now, 50 (67%) set no upper age limit and 12 (16%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · female · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 18 studies in Carcinoma, Ovarian Epithelial with a site in Switzerland, or all of them as a file.
02

Study summary

This is a single center prospective observational study to characterize the immune landscape of newly diagnosed epithelial ovarian cancer (OC).

Patients with newly diagnosed epithelial OC will be enrolled in 4 different cohorts: A) Newly diagnosed high grade serous or endometroid OC undergoing primary debulking surgery; B) Newly diagnosed high grade serous or endometroid OC undergoing neoadjuvant chemotherapy (NACT) followed by interval debulking surgery; C) Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking surgery; D) Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing NACT followed by interval debulking surgery. A cohort of women undergoing adnexectomy for benign pathology will be enrolled (cohort E) for comparative analysis.

Enrolled patients will be asked to provide the following biological samples at specified time points: archival and fresh tumor tissue, peripheral blood samples, rectal and vaginal swabs, ascites (when present).

The main aim of the study is to characterize the immune landscape of epithelial OC in tumor tissue and peripheral blood and correlate the presence of myeloid-derived suppressive cells (MDSCs) and other immune infiltrates and of the systemic immune response with progression free interval (PFI) in epithelial OC.

03

Conditions studied

  • Epithelial Ovarian Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with newly diagnosed epithelial ovarian cancer and subjects with bening gynecological conditions requiring surgery

Eligibility criteria

Inclusion criteria cohort A-D:

  • Suspicious diagnosis of epithelial ovarian cancer (subsequent histologically confirmation required)
  • Plan to undergo a surgical procedure for the management of epithelial ovarian cancer or recurrent ovarian cancer previously treated with conventional treatment and involved in the trial as group A-D
  • ≥18 years old
  • Performance Status ≤ 2
  • Written

Inclusion criteria cohort E:

  • Indication for adnexectomy for a benign gynecological condition
  • ≥18 years old
  • ECOG Performance Status ≤ 2
  • Written informed consent

Exclusion criteria cohort A-E:

  • Other active concomitant neoplasms that might confound the results of the planned analysis.
  • Ongoing active disease requiring treatment or condition of immune deficiency
  • Ongoing chronic treatment with or other immune suppressive agents at the time of study entry
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
74 participants (estimated)
Patient registry
No

Groups and cohorts

  • A

    Newly diagnosed high grade serous or endometroid OC undergoing primary debulking surgery

    Other: Collection of tumor samples, blood and vaginal and rectal swabs

  • B

    Newly diagnosed high grade serous or endometroid OC undergoing NACT followed by interval debulking surgery. This cohort also includes patients that will not be deemed suitable for interval debulking surgery following NACT

    Other: Collection of tumor samples, blood and vaginal and rectal swabs

  • C

    Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking surgery

    Other: Collection of tumor samples, blood and vaginal and rectal swabs

  • D

    Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing NACT followed by interval debulking surgery. This cohort also includes patients with the selected histological subtypes that will not be deemed suitable to interval debulking surgery following NACT

    Other: Collection of tumor samples, blood and vaginal and rectal swabs

  • E

    Women undergoing adnexectomy for benign pathology

Interventions

  • OtherCollection of tumor samples, blood and vaginal and rectal swabs

    The following biological samples will be collected at different time points, according to the specified cohort and after signing the inform consent form: tumor tissue (fresh and archival) or normal tissue (cohort E), ascites (when present), peripheral blood, rectal swab, vaginal swab.

06

What researchers measure

Primary outcomes

  1. Characterization of the immune cells infiltrate

    Expression of multiple immune cell markers will be assessed in samples from different subtypes of epithelial ovarian cancer by flow cytometric analysis. Percentages of individual immune cell populations among total tumor-infiltrating immune cells will be evaluated.

    Time frame: At the time of diagnosis in the tumor tissue and on blood. For patients receiving chemotherapy, assessment on blood after cycle 3 and 6

Secondary outcomes

  1. To define the prognostic value of the immune cells infiltrate

    The prognostic value of the immune cell populations identified by flow cytometry will be evaluated by calculating the correlation coefficient between the percentage of the immune cell population and the progression-free interval.

    Time frame: From diagnosis until disease progression or study termination, whichever will occur first

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2022 (actual). Primary completion is estimated for Dec 2026, 48 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2023
First posted
Aug 9, 2023
StartActual
Dec 20, 2022
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2028
Last update
Nov 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05984875
Lead sponsor
Oncology Institute of Southern Switzerland
Collaborators
Institute of Oncology Research
Responsible party
Sponsor
First posted
Aug 9, 2023
Start date
Dec 20, 2022
Primary completion
Dec 2026 (estimated)
Completion
Dec 2028 (estimated)
Last update
Nov 18, 2025

Study contacts

Ilaria Colombo, MD
Contact
ilaria.colombo@eoc.ch
+41764528823

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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