Official Title
Mutational Oncology in Clinical Practice: Development of a Comprehensive Cancer Genome Profile Pathway.
Brief Title
Mutational Oncology in Clinical Practice
Protocol ID
NCT06020625
Lead Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.
Study Period
Enrollment Count
20,000 participants
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
Filters
Genome Instability
Genetic Predisposition to Disease
Gene Rearrangement
NA
RECRUITING
ADULT
OLDER_ADULT