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Trial Title:
The Immune Landscape of Epithelial Ovarian Cancer
NCT ID:
NCT05984875
Condition:
Epithelial Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Collection of tumor samples, blood and vaginal and rectal swabs
Description:
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.
Arm group label:
A
Arm group label:
B
Arm group label:
C
Arm group label:
D
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.
Criteria for eligibility:
Study pop:
Patients with newly diagnosed epithelial ovarian cancer and subjects with bening
gynecological conditions requiring surgery
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Oncology Institute of Southern Switzerland
Address:
City:
Bellinzona
Zip:
6500
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Ilaria Colombo, MD
Phone:
+41764528823
Email:
ilaria.colombo@eoc.ch
Start date:
December 20, 2022
Completion date:
December 2026
Lead sponsor:
Agency:
Oncology Institute of Southern Switzerland
Agency class:
Other
Collaborator:
Agency:
Institute of Oncology Research
Agency class:
Other
Source:
Oncology Institute of Southern Switzerland
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05984875
