Trials / Recruiting
RecruitingNCT05984875
The Immune Landscape of Epithelial Ovarian Cancer
The Immune Landscape of Epithelial Ovarian Cancer: a Prospective Observational Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 74 (estimated)
- Sponsor
- Oncology Institute of Southern Switzerland · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Collection 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. |
Timeline
- Start date
- 2022-12-20
- Primary completion
- 2026-12-01
- Completion
- 2028-12-01
- First posted
- 2023-08-09
- Last updated
- 2025-11-18
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT05984875. Inclusion in this directory is not an endorsement.