Ovarian Cancer
Conditions
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.
Interventions
PROCEDURETumor and blood sample
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.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are prospectively assigned to an intervention consisting of a tumor biopsy.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DATA CORRELATION | 12 months | To correlate longitudinal protegenomic data to chemotherapy response score (CRS) |
Countries
Italy
Outcome results
None listed