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NCT Number: NCT06553742

High Definition Profiling of Ovarian Cancer Ascites

This project entails the collection of a prospective cohort of ascites (AS) samples from High Grade Serous Ovarian Cancer (HGSOC) patients.

High Grade Serous Ovarian Cancer (HGSOC) is a major cause of cancer-related mortality, due to the late-stage diagnosis and failure of surgery and chemotherapy (CHT) to eradicate the disease with no significant improvement in overall survival.

The primary objective of the project is to generate a comprehensive map of ascites cell components, detailing both their intrinsic features and the landscape of cellular interactions mediated by soluble factors in ascitic fluid.

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Key information

About this study

HGSOC is a major cause of cancer-related mortality, due to the late-stage diagnosis and failure of surgery and chemotherapy (CHT) to eradicate the disease with no significant improvement in overall survival.

In recent years, new therapeutic regimens are being tested to improve the care of HGSOC patients. These approaches include the use of poly-ADP-ribose polymerase inhibitors (PARPi) targeting Homology Directed Repair deficiency, anti-angiogenic drugs, such as anti-VEGF monoclonal antibodies, and immune checkpoint inhibitors, that target immune modulation induced by tumor and tumor-associated cells and inflammatory signals. Unfortunately, the outcome of such therapies has been to date either erratic or dismal.

This points to the acute need to identify new biomarkers predictive of treatment response, effectively geared to the clinical setting.

The primary objective of the project is to generate a comprehensive map of ascites cell components, detailing both their intrinsic features and the landscape of cellular interactions mediated by soluble factors in ascitic fluid. This will allow to define tumoral archetypes, reflecting HGSOC's endophenotypes, associated with prognosis in patients, possibly guiding future refined therapeutical paradigms for ovarian cancer patients and endowing researchers with a well-characterized multilayered dataset for future reference in the context of molecular dissection and target discovery paradigms.

Indeed, the combination of origin- and archetype-based stratification of HGSOC patients, will allow to better identify patients for which existing therapeutical regimens could be beneficial, such as the use of checkpoint inhibitors and anti-angiogenic drugs, that have been so far erratic in ameliorating patient's survival.

Who can participate

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

Inclusion criteria

  • Patients with suspicious or confirmed ovarian cancer pathology undergoing debulking surgery
  • Diagnosis of high grade serous ovarian cancer confirmed by histopathology assessment
  • Patients who provided written informed consent

Exclusion criteria

  • HIV-positive patients
  • HBV-positive patients
  • HCV-positive patients

Treatment and study plan

Primary outcomes

  1. Generation of a comprehensive map of ascites cell components

    Time frame: 48 month

    The samples will be stratified according to a DNA-methylation based signature specific for the tissue of origin of HGSOC.

    The cellular fraction derived from ascites samples will be profiled by single cell multiomics to define the cell populations associated to either the fallopian tube or ovarian surface epithelium origin. In parallel, ascitic fluid will be profiled by ELISA to define the soluble components present in the two HGSOC subtypes. These data will be used to generate a map of ascites cell components and biomarkers specific for the two tissues of origin of this disease. This map will be exploited to highlight possible therapeutic avenues for HGSOC patients.

Study contacts

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

Giuseppe Testa

CONTACT

[email protected]

+39 02 9437 5105

Pietro Lo Riso

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

High Definition Profiling of Ovarian Cancer Ascites for the Identification of Prognostic Biomarkers and Immunotherapeutic Targets: an Integrative Cell of Origin-guided Approach

Important dates

Study start
2024
Primary completion
2028
Study completion
2033
First posted
Aug 14, 2024
Registry last updated
Nov 20, 2024

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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