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Trial Title:
PROTEOGENOMIC SIGNATURES ANALYSIS IN OVARIAN CANCER
NCT ID:
NCT05953883
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Tumor and blood sample
Description:
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.
Arm group label:
Interventional
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Rome
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Camilla Nero, PhD
Phone:
0630158667
Email:
camilla.nero@policlinicogemelli.it
Start date:
November 17, 2022
Completion date:
March 17, 2024
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05953883
