Epithelial Ovarian CancerIOSI-GYNE-001NCT05984875
The Immune Landscape of Epithelial Ovarian Cancer
An observational study of Epithelial Ovarian Cancer, run by Oncology Institute of Southern Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Collection of tumor samples, blood and vaginal and rectal swabs
- How many people
- 74 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Dec 2022to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with newly diagnosed epithelial ovarian cancer and subjects with bening gynecological conditions requiring surgery
Who may be able to join
- 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
- ECOG Performance Status ≤ 2
- Written informed consent
- Indication for adnexectomy for a benign gynecological condition
Show all 9Show fewer
- ≥18 years old
- ECOG Performance Status ≤ 2
- Written informed consent
Who cannot join
- Other active concomitant neoplasms that might confound the results of the planned analysis.
- Ongoing active autoimmune disease requiring treatment or condition of immune deficiency
- Ongoing chronic treatment with steroids or other immune suppressive agents at the time of study entry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Oncology Institute of Southern Switzerland
Bellinzona, 6500
Ilaria Colombo, MD, +41764528823, ilaria.colombo@eoc.ch
About this study
Official title: The Immune Landscape of Epithelial Ovarian Cancer: a Prospective Observational Study
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.
Read more
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.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Collection of tumor samples, blood and vaginal and rectal swabs
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of tumor samples, blood and vaginal and rectal swabsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Newly diagnosed high grade serous or endometroid OC undergoing primary debulking surgery Receives: 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 Receives: 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 Receives: 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 Receives: Other: Collection of tumor samples, blood and vaginal and rectal swabs | |
| E | Women undergoing adnexectomy for benign pathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From diagnosis until disease progression or study termination, whichever will occur first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start20 Dec 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial 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
- Prospective
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncology Institute of Southern Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Oncology Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984875
- Sponsor's protocol ID
- IOSI-GYNE-001
- Acronym
- IOSI-GYNE-001
- Status last verified
- Nov 2025
- First submitted
- 24 Jul 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immune Landscape of Epithelial Ovarian Cancer: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05984875
- Acronym / sponsor ID
- IOSI-GYNE-001 / IOSI-GYNE-001
- Conditions
- Epithelial Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Oncology Institute of Southern SwitzerlandUniversity, hospital or other
- Collaborators
- Institute of Oncology Research
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Aug 2023 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: Collection of tumor samples, blood and vaginal and rectal swabsNewly diagnosed high grade serous or endometroid OC undergoing primary debulking surgery |
| B | – | Other: Collection of tumor samples, blood and vaginal and rectal swabsNewly 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 |
| C | – | Other: Collection of tumor samples, blood and vaginal and rectal swabsRare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking surgery |
| D | – | Other: Collection of tumor samples, blood and vaginal and rectal swabsRare 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 |
| E | – | –Women undergoing adnexectomy for benign pathology |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed epithelial ovarian cancer and subjects with bening gynecological conditions requiring surgery
Key inclusion criteria (9 listed)
- 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
- ECOG Performance Status ≤ 2
- Written informed consent
Key exclusion criteria (3 listed)
- Other active concomitant neoplasms that might confound the results of the planned analysis.
- Ongoing active autoimmune disease requiring treatment or condition of immune deficiency
- Ongoing chronic treatment with steroids or other immune suppressive agents at the time of study entry
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 |
|---|---|---|
| Collection of tumor samples, blood and vaginal and rectal swabsThe 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. | Other | A, B, C, D |
Primary outcome
Characterization of the immune cells infiltrate
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
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.
1 secondary outcome
To define the prognostic value of the immune cells infiltrate
Time frame: From diagnosis until disease progression or study termination, whichever will occur first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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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.
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 Ovarian Cancer, run by Oncology Institute of Southern Switzerland at 1 site in Switzerland.
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 9 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilaria Colombo, MD (+41764528823, ilaria.colombo@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the immune cells infiltrate (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). 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 18 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.