Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
74 participants
OBSERVATIONAL
2022-12-20
2028-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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A
Newly diagnosed high grade serous or endometroid OC undergoing primary debulking surgery
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.
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
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.
C
Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking surgery
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.
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
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.
E
Women undergoing adnexectomy for benign pathology
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Institute of Oncology Research
UNKNOWN
Oncology Institute of Southern Switzerland
OTHER
Responsible Party
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Locations
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Oncology Institute of Southern Switzerland
Bellinzona, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IOSI-GYNE-001
Identifier Type: -
Identifier Source: org_study_id
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