Clinical trial NCT05984875: The Immune Landscape of Epithelial Ovarian Cancer
Official title: The Immune Landscape of Epithelial Ovarian Cancer: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epithelial Ovarian Cancer
Lead sponsor: Oncology Institute of Southern Switzerland
Sponsor class: OTHER
Collaborators: name: Institute of Oncology Research
First posted: 2023-08-09
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed epithelial ovarian cancer and subjects with bening gynecological conditions requiring surgery

Brief 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 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

Primary outcomes:
measure: Characterization of the immune cells infiltrate
timeFrame: At the time of diagnosis in the tumor tissue and on blood. For patients receiving chemotherapy, assessment on blood after cycle 3 and 6
Secondary outcomes:
measure: To define the prognostic value of the immune cells infiltrate
timeFrame: From diagnosis until disease progression or study termination, whichever will occur first
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland
Study officials:
References: