Clinical trial · Observational
The Immune Landscape of Epithelial Ovarian Cancer
The Immune Landscape of Epithelial Ovarian Cancer: a Prospective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collection of tumor samples, blood and vaginal and rectal swabs | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- A
- description
- Newly diagnosed high grade serous or endometroid OC undergoing primary debulking surgery
- interventionNames
- Other: Collection of tumor samples, blood and vaginal and rectal swabs
- label
- B
- description
- 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
- interventionNames
- Other: Collection of tumor samples, blood and vaginal and rectal swabs
- label
- C
- description
- Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking surgery
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available