PROTEOGENOMIC SIGNATURES ANALYSIS IN OVARIAN CANCER

Study Overview
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Brief Summary
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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.

Official Title
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PROTEOGENOMIC SIGNATURES ANALYSIS IN OVARIAN CANCER: LONGITUDINAL MODIFICATION ON TUMOR TISSUE BEFORE AND AFTER PLATINUM-BASED NEOADJUVANT CHEMOTHERAPY

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Procedure: Tumor and blood sample


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br> | Procedure: Tumor and blood sample<br>* Analyzing proteogenomic profiles in order to find individual platinum-induced modifications on tumor tissue of HGSOC according to chemotherapy response score (CRS). Whole genome sequencing (WGS), transcriptomic (RNAseq) and proteomics analyses on OC tissue samples before and after a standard platinum-based chemotherapy will be carried out and correlated to clinical variables.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DATA CORRELATION | To correlate longitudinal protegenomic data to chemotherapy response score (CRS) | 12 months |