The Immune Landscape of Epithelial Ovarian Cancer

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Characterization of the immune cells infiltrate [Срок оценки: At the time of diagnosis in the tumor tissue and on blood. For patients receiving chemotherapy, assessment on blood after cycle 3 and 6]

Вторичные конечные точки (1)

• To define the prognostic value of the immune cells infiltrate [Срок оценки: From diagnosis until disease progression or study termination, whichever will occur first]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 1 центр

• Oncology Institute of Southern Switzerland — Bellinzona

Идентификаторы

NCT: NCT05984875 · IOSI-GYNE-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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