Proteogenomic Signatures Analysis In Ovarian Cancer

NCT05953883 | Active Not Recruiting

• 1 other identifier: 5288
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• DATA CORRELATION

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

  12 months

Study Arms (1)

Interventional

EXPERIMENTAL

Participants are prospectively assigned to an intervention consisting of a tumor biopsy.

Procedure: Tumor and blood sample

Interventions

Tumor and blood sample PROCEDURE

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.

Interventional

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Tumor Burden; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Body Weights and Measures; Anthropometry; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Camilla Nero

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are prospectively assigned to an intervention consisting of a tumor biopsy.

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 20, 2023
• Study Start: November 17, 2022
• Primary Completion: November 17, 2023
• Study Completion: March 17, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Locations

IT (1)