The Immune Landscape of Epithelial Ovarian Cancer
- Conditions
- Epithelial Ovarian Cancer
- Interventions
- Other: Collection of tumor samples, blood and vaginal and rectal swabs
- Registration Number
- NCT05984875
- Lead Sponsor
- Oncology Institute of Southern Switzerland
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 74
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A Collection of tumor samples, blood and vaginal and rectal swabs Newly diagnosed high grade serous or endometroid OC undergoing primary debulking surgery B Collection of tumor samples, blood and vaginal and rectal swabs 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 D Collection of tumor samples, blood and vaginal and rectal swabs 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 C Collection of tumor samples, blood and vaginal and rectal swabs Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking surgery
- Primary Outcome Measures
Name Time Method Characterization of the immune cells infiltrate 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.
- Secondary Outcome Measures
Name Time Method To define the prognostic value of the immune cells infiltrate From diagnosis until disease progression or study termination, whichever will occur first 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.
Trial Locations
- Locations (1)
Oncology Institute of Southern Switzerland
🇨🇭Bellinzona, Switzerland