High Definition Profiling of Ovarian Cancer Ascites

November 18, 2024 updated by: European Institute of Oncology

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy
        • European Institute of Oncology
        • Contact:
          • Giuseppe Testa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

HGSOC samples are provided by the European Institute of Oncology biobank. All patients will be provided written informed consent.

Patients with suspicious or confirmed ovarian cancer pathology undergoing debulking surgery will be included in the protocol. Only samples diagnosed as high grade serous ovarian cancer confirmed by histopathology assessment will be included in the following analyses.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Investigators

  • Principal Investigator: Giuseppe Testa, European Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L2-016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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