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NCT Number: NCT05984875

The Immune Landscape of Epithelial Ovarian Cancer

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.

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Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Oncology Institute of Southern Switzerland

Bellinzona, 6500, Switzerland

Location status: Recruiting

Location contact

Ilaria Colombo, MD

CONTACT

[email protected]

+41764528823

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of tumor samples, blood and vaginal and rectal swabs

Other

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.

Primary outcomes

  1. Characterization of the immune cells infiltrate

    Time frame: At the time of diagnosis in the tumor tissue and on blood. For patients receiving chemotherapy, assessment on blood after cycle 3 and 6

    Expression of multiple immune cell markers will be assessed in samples from different subtypes of epithelial ovarian cancer by flow cytometric analysis. Percentages of individual immune cell populations among total tumor-infiltrating immune cells will be evaluated.

Secondary outcomes

  1. To define the prognostic value of the immune cells infiltrate

    Time frame: From diagnosis until disease progression or study termination, whichever will occur first

    The prognostic value of the immune cell populations identified by flow cytometry will be evaluated by calculating the correlation coefficient between the percentage of the immune cell population and the progression-free interval.

Study contacts

Contact information is provided by the study sponsor or research team.

Ilaria Colombo, MD

CONTACT

[email protected]

+41764528823

Sponsors and collaborators

Lead sponsor

Oncology Institute of Southern Switzerland

Other

Collaborators

  • Institute of Oncology Research

Registry information

Official study title

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

Acronym: IOSI-GYNE-001

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Aug 9, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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