The Immune Landscape of Epithelial Ovarian Cancer
ConditionEpithelial Ovarian Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorOncology Institute of Southern Switzerland
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Collection of tumor samples, blood and vaginal and rectal swabs
Treatment groups
74 Participants
are divided into 5 treatment groupsSponsors and collaborators
Oncology Institute of Southern Switzerland
Lead sponsor
Institute of Oncology Research
Collaborator
Source ClinicalTrials.gov