The Immune Landscape of Epithelial Ovarian Cancer: a Prospective Observational Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

• Indication for adnexectomy for a benign gynecological condition

• ≥18 years old

• ECOG Performance Status ≤ 2

• Written informed consent

Locations
Other Locations
Switzerland
Oncology Institute of Southern Switzerland
RECRUITING
Bellinzona
Contact Information
Primary
Ilaria Colombo, MD
ilaria.colombo@eoc.ch
+41764528823
Time Frame
Start Date: 2022-12-20
Estimated Completion Date: 2026-12
Participants
Target number of participants: 74
Treatments
A
Newly diagnosed high grade serous or endometroid OC undergoing primary debulking surgery
B
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
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. This cohort also includes patients with the selected histological subtypes that will not be deemed suitable to interval debulking surgery following NACT
E
Women undergoing adnexectomy for benign pathology
Sponsors
Collaborators: Institute of Oncology Research
Leads: Oncology Institute of Southern Switzerland

This content was sourced from clinicaltrials.gov

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