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| Name | Class |
|---|---|
| Institute of Oncology Research | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Newly diagnosed high grade serous or endometroid OC undergoing primary debulking surgery |
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| 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 |
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| C | Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking surgery |
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| 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 |
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| E | Women undergoing adnexectomy for benign pathology |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion criteria cohort A-D:
Inclusion criteria cohort E:
Exclusion criteria cohort A-E:
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Patients with newly diagnosed epithelial ovarian cancer and subjects with bening gynecological conditions requiring surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilaria Colombo, MD | Contact | +41764528823 | ilaria.colombo@eoc.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Institute of Southern Switzerland | Recruiting | Bellinzona | 6500 | Switzerland |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |