RECRUITINGOBSERVATIONAL

The Immune Landscape of Epithelial Ovarian Cancer

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

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.

Who May Be Eligible (Plain English)

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 willing to sign a consent form Inclusion criteria cohort E: - Indication for adnexectomy for a benign gynecological condition - ≥18 years old - ECOG Performance Status ≤ 2 - Written willing to sign a consent form Exclusion criteria cohort A-E: - Other active concomitant neoplasms that might confound the results of the planned analysis. - Ongoing active autoimmune conditions (where your immune system attacks your own body) requiring treatment or condition of immune deficiency - Ongoing chronic treatment with steroids or other immune suppressive agents at the time of study entry Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

OTHER

Collection of tumor samples, blood and vaginal and rectal swabs

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.

Locations (1)

Oncology Institute of Southern Switzerland

Bellinzona, Switzerland