The Immune Landscape of Epithelial Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collection of tumor samples, blood and vaginal and rectal swabs.
- Who it may be relevant to
- Registry conditions: Epithelial Ovarian Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Immune Landscape of Epithelial Ovarian Cancer: a Prospective Observational Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Characterization of the immune cells infiltrate [Time frame: 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 (1)
- To define the prognostic value of the immune cells infiltrate [Time frame: From diagnosis until disease progression or study termination, whichever will occur first]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- Oncology Institute of Southern Switzerland — Bellinzona
Identifiers
NCT: NCT05984875 · IOSI-GYNE-001