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Mutational Oncology in Clinical Practice (FPG-500)

Primary Purpose

Genome Instability, Genetic Predisposition to Disease, Gene Rearrangement

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

About this trial

This is an interventional health services research trial for Genome Instability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

- Patients with neoplasm of the lung, breast, ovary, pancreas, prostate, colorectum, melanoma, GIST, thyroid neoplasm, endometrium, and cholangiocarcinoma: BREAST Locally advanced or metastatic, hormone-responsive, HER2-negative breast neoplasm, progressing after endocrine therapy. LUNG Metastatic disease. OVARY Any stage of nonmucinous, non-borderline epithelial carcinoma of the ovary, fallopian tube, or primary peritoneal carcinoma. PANCREAS Metastatic disease. PROSTATE Metastatic castration-resistant disease. COLORECTUM Metastatic disease. MELANOMA Stage IV or stage III undergoing surgery. 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. THYROID ENDOMETRIUM CHOLANGIOCARCINOMA

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

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

Secondary Outcome Measures

Full Information

First Posted
May 8, 2023
Last Updated
August 30, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT06020625
Brief Title
Mutational Oncology in Clinical Practice
Acronym
FPG-500
Official Title
Mutational Oncology in Clinical Practice: Development of a Comprehensive Cancer Genome Profile Pathway.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
January 2032 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genome Instability, Genetic Predisposition to Disease, Gene Rearrangement

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Intervention Type
Genetic
Intervention Name(s)
Diagnostic Test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comprehensive Genome Profiling
Description
Evaluate the impact and efficacy of a 500 cancer genes profiling in an Italian referral centre
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
- Patients with neoplasm of the lung, breast, ovary, pancreas, prostate, colorectum, melanoma, GIST, thyroid neoplasm, endometrium, and cholangiocarcinoma: BREAST Locally advanced or metastatic, hormone-responsive, HER2-negative breast neoplasm, progressing after endocrine therapy. LUNG Metastatic disease. OVARY Any stage of nonmucinous, non-borderline epithelial carcinoma of the ovary, fallopian tube, or primary peritoneal carcinoma. PANCREAS Metastatic disease. PROSTATE Metastatic castration-resistant disease. COLORECTUM Metastatic disease. MELANOMA Stage IV or stage III undergoing surgery. 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. THYROID ENDOMETRIUM CHOLANGIOCARCINOMA
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni Scambia
Phone
0630158668
Email
giovanni.scambia@policlinicogemelli.it
First Name & Middle Initial & Last Name or Official Title & Degree
Camilla Nero
Phone
0630158668
Email
camilla.nero@policlinicogemelli.it
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
Giovanni Scambia
Email
giovanni.scambia@policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Camilla Nero
Email
camilla.nero@policlinicogemelli.it

12. IPD Sharing Statement

Learn more about this trial

Mutational Oncology in Clinical Practice

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