The Immune Landscape of Epithelial Ovarian Cancer

Study Overview
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Brief Summary
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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.

Official Title
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The Immune Landscape of Epithelial Ovarian Cancer: a Prospective Observational Study

Conditions
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Epithelial Ovarian Cancer

Intervention / Treatment
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* Other: Collection of tumor samples, blood and vaginal and rectal swabs


Participation Criteria
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Eligibility Criteria
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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 ECOG Performance Status ≤ 2 Written informed consent 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Newly diagnosed high grade serous or endometroid OC undergoing primary debulking surgery | Other: Collection of tumor samples, blood and vaginal and rectal swabs<br>* 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.<br>|
| B<br>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<br>* 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.<br>|
| C<br>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<br>* 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.<br>|
| D<br>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<br>* 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.<br>|
| E<br>Women undergoing adnexectomy for benign pathology | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From diagnosis until disease progression or study termination, whichever will occur first |