Genome InstabilityFPG-500NCT06020625
Mutational Oncology in Clinical Practice
A study testing Diagnostic Test in people with Genome Instability and Genetic Predisposition to Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genome Instability, Genetic Predisposition to Disease, Gene Rearrangement
- What is being tested?
- Diagnostic Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to Jan 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome
Giovanni Scambia, giovanni.scambia@policlinicogemelli.it
Camilla Nero, camilla.nero@policlinicogemelli.it
About this study
Official title: Mutational Oncology in Clinical Practice: Development of a Comprehensive Cancer Genome Profile Pathway.
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.
- Being tested
- Diagnostic Test
- Medical subject headings
- Genomic Instability, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic TestGenetic
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 group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Not described Receives: Genetic: Diagnostic Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Genome Profiling
Evaluate the impact and efficacy of a 500 cancer genes profiling in an Italian referral centre
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Jan 2022
- Primary completion1 May 2023
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Genome InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020625
- Sponsor's protocol ID
- 3837
- Acronym
- FPG-500
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mastrantoni L, Camarda F, Parrillo C, Persiani F, Trozzi R, Pasciuto T, Manfredelli M, Minucci A, De Paolis E, Capasso I, Iacobelli V, Perri MT, Zannoni GF, Fanfani F, Scambia G, Nero C. Gene actionability according to the ESMO Scale for Clinical Actionability of molecular Targets (ESCAT) in No Specific Molecular Profile (NSMP) endometrial cancer. ESMO Open. 2025 Sep;10(9):105755. doi: 10.1016/j.esmoop.2025.105755. Epub 2025 Sep 3.
PubMed 40907210Vita E, Scala A, Vitale A, Mastrantoni L, Evangelista J, D'Auria F, Stefani A, Monaca F, Russo J, Horn G, Troisi P, Cosmai A, Polidori S, Di Salvatore M, De Paolis E, Minucci A, Nero C, Trisolini R, Cancellieri A, Scambia G, Tortora G, Bria E. Network analysis of NRG1 variants of uncertain significance (VUSes) in advanced non-small-cell lung cancer and their prognostic role in EGFR-mutant patients treated with first-line osimertinib. ESMO Open. 2025 Sep;10(9):105556. doi: 10.1016/j.esmoop.2025.105556. Epub 2025 Aug 29.
PubMed 40885102Vitale A, Mastrantoni L, Russo J, Giacomini F, Giannarelli D, Duranti S, Vita E, Nero C, D'Argento E, Pasciuto T, Giaco L, Di Salvatore M, Panfili A, Stefani A, Cancellieri A, Lococo F, De Paolis E, Livi V, Daniele G, Trisolini R, Minucci A, Margaritora S, Lorusso D, Normanno N, Scambia G, Tortora G, Bria E. Impact of Comprehensive Genome Profiling on the Management of Advanced Non-Small Cell Lung Cancer: Preliminary Results From the Lung Cancer Cohort of the FPG500 Program. JCO Precis Oncol. 2024 Oct;8:e2400297. doi: 10.1200/PO.24.00297. Epub 2024 Oct 7.
PubMed 39374480
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mutational Oncology in Clinical Practice: Development of a Comprehensive Cancer Genome Profile Pathway.
- ClinicalTrials.gov ID
- NCT06020625
- Acronym / sponsor ID
- FPG-500 / 3837
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- Jan 2032 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Genetic: Diagnostic Test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic TestIn 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. | Genetic | Interventional |
Primary outcome
Comprehensive Genome Profiling
Time frame: 5 years
Evaluate the impact and efficacy of a 500 cancer genes profiling in an Italian referral centre
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Derived from this study: PubMed 40907210Mastrantoni L, Camarda F, Parrillo C, Persiani F, Trozzi R, Pasciuto T, Manfredelli M, Minucci A, De Paolis E, Capasso I, Iacobelli V, Perri MT, Zannoni GF, Fanfani F, Scambia G, Nero C. Gene actionability according to the ESMO Scale for Clinical Actionability of molecular Targets (ESCAT) in No Specific Molecular Profile (NSMP) endometrial cancer. ESMO Open. 2025 Sep;10(9):105755. doi: 10.1016/j.esmoop.2025.105755. Epub 2025 Sep 3.
- Derived from this study: PubMed 40885102Vita E, Scala A, Vitale A, Mastrantoni L, Evangelista J, D'Auria F, Stefani A, Monaca F, Russo J, Horn G, Troisi P, Cosmai A, Polidori S, Di Salvatore M, De Paolis E, Minucci A, Nero C, Trisolini R, Cancellieri A, Scambia G, Tortora G, Bria E. Network analysis of NRG1 variants of uncertain significance (VUSes) in advanced non-small-cell lung cancer and their prognostic role in EGFR-mutant patients treated with first-line osimertinib. ESMO Open. 2025 Sep;10(9):105556. doi: 10.1016/j.esmoop.2025.105556. Epub 2025 Aug 29.
- Derived from this study: PubMed 39374480Vitale A, Mastrantoni L, Russo J, Giacomini F, Giannarelli D, Duranti S, Vita E, Nero C, D'Argento E, Pasciuto T, Giaco L, Di Salvatore M, Panfili A, Stefani A, Cancellieri A, Lococo F, De Paolis E, Livi V, Daniele G, Trisolini R, Minucci A, Margaritora S, Lorusso D, Normanno N, Scambia G, Tortora G, Bria E. Impact of Comprehensive Genome Profiling on the Management of Advanced Non-Small Cell Lung Cancer: Preliminary Results From the Lung Cancer Cohort of the FPG500 Program. JCO Precis Oncol. 2024 Oct;8:e2400297. doi: 10.1200/PO.24.00297. Epub 2024 Oct 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Test in people with Genome Instability and Genetic Predisposition to Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Scambia (0630158668, giovanni.scambia@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Genome Profiling (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06020625, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023; AzTrials last refreshed its copy on 30 Oct 2026.