NCT05984875 The Immune Landscape of Epithelial Ovarian Cancer
| NCT ID | NCT05984875 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oncology Institute of Southern Switzerland |
| Condition | Epithelial Ovarian Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 74 participants |
| Start Date | 2022-12-20 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 74 participants in total. It began in 2022-12-20 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05984875 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Epithelial Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05984875 currently recruiting?
Yes, NCT05984875 is actively recruiting participants. Contact the research team at ilaria.colombo@eoc.ch for enrollment information.
Where is the NCT05984875 trial being conducted?
This trial is being conducted at Bellinzona, Switzerland.
Who is sponsoring the NCT05984875 clinical trial?
NCT05984875 is sponsored by Oncology Institute of Southern Switzerland. The trial plans to enroll 74 participants.
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