search
Back to results

PROTEOGENOMIC SIGNATURES ANALYSIS IN OVARIAN CANCER (PROGENITOR)

Primary Purpose

Ovarian Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Tumor and blood sample
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional

Arm Description

Outcomes

Primary Outcome Measures

DATA CORRELATION
To correlate longitudinal protegenomic data to chemotherapy response score (CRS)

Secondary Outcome Measures

Full Information

First Posted
June 21, 2023
Last Updated
July 18, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
search

1. Study Identification

Unique Protocol Identification Number
NCT05953883
Brief Title
PROTEOGENOMIC SIGNATURES ANALYSIS IN OVARIAN CANCER
Acronym
PROGENITOR
Official Title
PROTEOGENOMIC SIGNATURES ANALYSIS IN OVARIAN CANCER: LONGITUDINAL MODIFICATION ON TUMOR TISSUE BEFORE AND AFTER PLATINUM-BASED NEOADJUVANT CHEMOTHERAPY
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
November 17, 2023 (Anticipated)
Study Completion Date
March 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Tumor and blood sample
Intervention 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.
Primary Outcome Measure Information:
Title
DATA CORRELATION
Description
To correlate longitudinal protegenomic data to chemotherapy response score (CRS)
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla Nero, PhD
Phone
0630158667
Email
camilla.nero@policlinicogemelli.it

12. IPD Sharing Statement

Learn more about this trial

PROTEOGENOMIC SIGNATURES ANALYSIS IN OVARIAN CANCER

We'll reach out to this number within 24 hrs