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Clinical Trials/NCT06020625
NCT06020625RecruitingNot Applicable

Mutational Oncology in Clinical Practice: Development of a Comprehensive Cancer Genome Profile Pathway.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country20,000 target enrollmentStarted: January 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20,000
Locations
1
Primary Endpoint
Comprehensive Genome Profiling

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion 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.
  • ENDOMETRIUM
  • CHOLANGIOCARCINOMA

Exclusion Criteria

  • Not provided

Arms & Interventions

Interventional

Experimental

Intervention: Diagnostic Test (Genetic)

Outcomes

Primary Outcomes

Comprehensive Genome Profiling

Time Frame: 5 years

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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