The Immune Landscape of Epithelial Ovarian Cancer

NCT05984875 | Recruiting

• 1 other identifier: IOSI-GYNE-001
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epithelial Ovarian Cancer

Outcome Measures

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.

  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

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

Study Arms (5)

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

Collection of tumor samples, blood and vaginal and rectal swabs OTHER

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.

A; B; C; D

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• ≥18 years old
• ECOG Performance Status ≤ 2
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Oncology Institute of Southern Switzerland: lead
• Institute of Oncology Research: collaborator

Study Sites (1)

Oncology Institute of Southern Switzerland

Bellinzona, 6500, Switzerland

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Ilaria Colombo, MD

CONTACT

+41764528823; ilaria.colombo@eoc.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 9, 2023
• Study Start: December 20, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)