Mutational Oncology in Clinical Practice (FPG-500)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Genome Instability; Genetic Predisposition to Disease; Gene Rearrangement

Treatments: Genetic: Diagnostic Test

Study type: Interventional

Funder types: Other

Identifiers

NCT06020625

3837 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20,000 participants in 1 patient group

Interventional

Experimental group

Treatment:

Genetic: Diagnostic Test