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Mutational Oncology in Clinical Practice (FPG-500)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06020625
Recruitment Status : Recruiting
First Posted : August 31, 2023
Last Update Posted : August 31, 2023
Sponsor:
Information provided by (Responsible Party):
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Description
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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.


Condition or disease Intervention/treatment Phase
Genome Instability Genetic Predisposition to Disease Gene Rearrangement Genetic: Diagnostic Test Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Mutational Oncology in Clinical Practice: Development of a Comprehensive Cancer Genome Profile Pathway.
Actual Study Start Date : January 1, 2022
Actual Primary Completion Date : May 1, 2023
Estimated Study Completion Date : January 2032

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Interventional 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.


Outcome Measures
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Primary Outcome Measures :
  1. Comprehensive Genome Profiling [ Time Frame: 5 years ]
    Evaluate the impact and efficacy of a 500 cancer genes profiling in an Italian referral centre


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06020625


Contacts
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Contact: Giovanni Scambia 0630158668 giovanni.scambia@policlinicogemelli.it
Contact: Camilla Nero 0630158668 camilla.nero@policlinicogemelli.it

Locations
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Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Recruiting
Rome, Italy
Contact: Giovanni Scambia       giovanni.scambia@policlinicogemelli.it   
Contact: Camilla Nero       camilla.nero@policlinicogemelli.it   
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
More Information
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Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT06020625    
Other Study ID Numbers: 3837
First Posted: August 31, 2023    Key Record Dates
Last Update Posted: August 31, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Genetic Predisposition to Disease
Genomic Instability
Disease Susceptibility
Disease Attributes
Pathologic Processes