Mutational Oncology in Clinical Practice (FPG-500)

• ClinicalTrials.gov Identifier: NCT06020625
• Recruitment Status: Recruiting
• First Posted: August 31, 2023
• Last Update Posted: August 31, 2023
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Information provided by (Responsible Party): Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Tracking Information

• First Submitted Date: May 8, 2023
• First Posted Date: August 31, 2023
• Last Update Posted Date: August 31, 2023
• Actual Study Start Date: January 1, 2022
• Actual Primary Completion Date: May 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 30, 2023)

Comprehensive Genome Profiling [ Time Frame: 5 years ]

Evaluate the impact and efficacy of a 500 cancer genes profiling in an Italian referral centre

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mutational Oncology in Clinical Practice
• Official Title: Mutational Oncology in Clinical Practice: Development of a Comprehensive Cancer Genome Profile Pathway.

Brief Summary

The study of biological profiling is of fundamental importance in the diagnosis and treatment of many diseases, particularly oncological ones, and for this reason, the integration of molecular characterization into clinical practice becomes essential. NGS allows a high number of samples to be sequenced simultaneously, generating a great deal of genomic information in a short time and at reasonable cost. This information is of fundamental importance for the study of oncogenic drivers and gene alterations that may have a prognostic and/or predictive role in response to new molecularly targeted drugs.

Policlinico A. Gemelli has begun a process of internal reorganization of the research infrastructure following its recognition in 2018 as an Institute of Hospitalization and Treatment with Scientific Character (IRCCS) for its commitment to the disciplines of "Personalized Medicine" and "Innovative Biotechnology." In particular, with regard to genomics, will be equipped with a state-of-the-art technological asset that includes a fully automated process for sample preparation and the highest gene sequencing power available today. This condition makes it possible to perform extensive genomic profiling for large numbers of patients at low cost and in reasonable time.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• Genome Instability
• Genetic Predisposition to Disease
• Gene Rearrangement

Intervention

Genetic: Diagnostic Test

In order to proceed with molecular characterization, the tumor sample already taken for histological diagnosis will undergo DNA and RNA extraction, which will be analyzed for qualitative and quantitative evaluation. Based on the quantitative data, the method to be used for profiling will be decided.

Multigenic genomic profiling will be performed for each patient on already taken tumor tissue using different panels depending on the quality and quantity of nucleic acids, in particular the following will be used: comprehensive Genome Profiling (CGP, ≥500 genes), if at least 40 ng of material is available; Profiling with identification of actionable mutations by targeted sequencing with panels of size >50 genes, if <40 ng material available.

Study Arms

Experimental: Interventional

Intervention: Genetic: Diagnostic Test

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 30, 2023): 20000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2032
• Actual Primary Completion Date: May 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

- Patients with neoplasm of the lung, breast, ovary, pancreas, prostate, colorectum, melanoma, GIST, thyroid neoplasm, endometrium, and cholangiocarcinoma:

1. BREAST Locally advanced or metastatic, hormone-responsive, HER2-negative breast neoplasm, progressing after endocrine therapy.
2. LUNG Metastatic disease.
3. OVARY Any stage of nonmucinous, non-borderline epithelial carcinoma of the ovary, fallopian tube, or primary peritoneal carcinoma.
4. PANCREAS Metastatic disease.
5. PROSTATE Metastatic castration-resistant disease.
6. COLORECTUM Metastatic disease.
7. MELANOMA Stage IV or stage III undergoing surgery.
8. GIST Profiling of c-KIT in case of metastatic disease or for patients undergoing surgery and of PDGFRα for all patients with inoperable or metastatic disease.
9. THYROID
10. ENDOMETRIUM
11. CHOLANGIOCARCINOMA

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Giovanni Scambia; 0630158668; giovanni.scambia@policlinicogemelli.it

Contact: Camilla Nero; 0630158668; camilla.nero@policlinicogemelli.it

• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT06020625
• Other Study ID Numbers: 3837
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Original Responsible Party: Same as current
• Current Study Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Verification Date: May 2023