High Definition Profiling of Ovarian Cancer Ascites

NCT06553742 | Not Yet Recruiting

• 1 other identifier: L2-016
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Cancer; High Grade Ovarian Serous Adenocarcinoma; Ascites

Outcome Measures

Primary Outcomes (1)

• Generation of a comprehensive map of ascites cell components

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

50 AS pre-chemotherapy samples will be collected at Istituto Europeo di Oncologia (IEO) AS samples will be centrifuged, lysis of red blood cells will be performed, and the cell pellet will be viable frozen. Frozen vials will be processed to isolate the tumor and non-immune tumor-associated cell populations (CD45-), or gradient separation to isolate immune cells. The CD45- population will be used for: i) genomic DNA extraction that will be subjected to DNA methylation profiling (EPIC 850k arrays, Illumina) and origin-based stratification. ii) generation of sMOCS, that allow to enrich for cancer stem cells, through label-free FACS sorting into 96-well low attachment plates. iii) single cell transcript profiling of both CD45- cells and dissociated sMOCS

MeSH Terms

Conditions

Ovarian Neoplasms; Ascites

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Testa

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Testa

CONTACT

+39 02 9437 5105; giuseppe.testa@ieo.it

Pietro Lo Riso

CONTACT

pietro.loriso@ieo.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 14, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2033
• Last Updated: November 20, 2024

Record last verified: 2024-07

Locations

IT (1)