PROGENITOR: PROTEOGENOMIC SIGNATURES ANALYSIS IN OVARIAN CANCER

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Recruiting

CT.gov ID

NCT05953883

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Procedure: Tumor and blood sample	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 17, 2022

Anticipated Primary Completion Date :

Nov 17, 2023

Anticipated Study Completion Date :

Mar 17, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interventional	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.

Arm

Intervention/Treatment

Experimental: Interventional

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.

Outcome Measures

Primary Outcome Measures

DATA CORRELATION [12 months]
To correlate longitudinal protegenomic data to chemotherapy response score (CRS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome		Italy

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT05953883

Other Study ID Numbers:

5288

First Posted:

Jul 20, 2023

Last Update Posted:

Jul 20, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of Jul 20, 2023