The Immune Landscape of Epithelial Ovarian Cancer (IOSI-GYNE-001)

Oncology Institute of Southern Switzerland (IOSI)

Status: Enrolling

Conditions: Epithelial Ovarian Cancer

Treatments: Other: Collection of tumor samples, blood and vaginal and rectal swabs

Study type: Observational

Funder types: Other

Identifiers

NCT05984875

IOSI-GYNE-001

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

74 participants in 5 patient groups

A

Description:

Newly diagnosed high grade serous or endometroid OC undergoing primary debulking surgery

Treatment:

Other: Collection of tumor samples, blood and vaginal and rectal swabs

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

Treatment:

Other: Collection of tumor samples, blood and vaginal and rectal swabs

C

Description:

Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking surgery

Treatment:

Other: Collection of tumor samples, blood and vaginal and rectal swabs

D

Description:

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

Treatment:

Other: Collection of tumor samples, blood and vaginal and rectal swabs

E

Description:

Women undergoing adnexectomy for benign pathology