PROTEOGENOMIC SIGNATURES ANALYSIS IN OVARIAN CANCER

Ovarian Cancer Clinical Trial

— PROGENITOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05953883
• Other study ID #: 5288
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: March 17, 2024

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 17, 2024
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• Tumor 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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DATA CORRELATION	To correlate longitudinal protegenomic data to chemotherapy response score (CRS)	12 months