Proteogenomic Signatures Analysis In Ovarian Cancer

Not Applicable

Active, not recruiting

• Conditions: Ovarian Cancer
• Interventions: Procedure: Tumor and blood sample

• Registration Number: NCT05953883
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

Proteogenomic analysis to detect individual platinum-induced modifications on tumor tissue of HGSC according to chemotherapy response score (CRS), using a combined approach of High resolution liquid chromatography mass Spectrometry based platform (HR-LC-MS/MS and advanced immunometric methods on illumine platform); multiple supervised machine learning algorithms will be used to discover proteogenomic signatures and biological processes associated with platinum modification during the neoadjuvant chemotherapy treatment. These results contribute to precision medicine by building an accurate proteogenomic profile of ovarian cancer, in order to better understand the underlying mechanisms of different chemotherapy response among affected patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-17
• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-20
• Primary Completion: 2023-11-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Study Completion: 2025-03-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

Newly diagnosed advanced International Federation of Gynecology and Obstetrics (FIGO) stage III A or greater epithelial ovarian cancer addressed to neoadjuvant chemotherapy (NACT) and interval debulking surgery (IDS);

Availability of freshly frozen tissue and FFPE tissue from both exploratory laparoscopy (baseline) and IDS;

Age between 18 and 80 years;

Estimated life expectancy of at least 4 weeks;

Signed informed consent

Exclusion Criteria

Non-serous histology at frozen section;

Patients with a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (> 10 mg equivalent prednisone/daily) or any other form of immunosuppressive therapy within 7 days prior to the enrollment;

Previous diagnosis of cancer within 5 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional	Tumor and blood sample	-

Primary Outcome Measures

Name	Time	Method
DATA CORRELATION	12 months	To correlate longitudinal protegenomic data to chemotherapy response score (CRS)

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy