Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06020625

Mutational Oncology in Clinical Practice

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2023-08-31

20000

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Mutational Oncology in Clinical Practice

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with neoplasm of the lung, breast, ovary, pancreas, prostate, colorectum, melanoma, GIST, thyroid neoplasm, endometrium, and cholangiocarcinoma
  • Breast cancer that is locally advanced or metastatic, hormone-responsive, HER2-negative, progressing after endocrine therapy
  • Metastatic lung cancer
  • Any stage of nonmucinous, non-borderline epithelial carcinoma of ovary, fallopian tube, or primary peritoneal carcinoma
  • Metastatic pancreatic cancer
  • Metastatic castration-resistant prostate cancer
  • Metastatic colorectal cancer
  • Melanoma stage IV or stage III undergoing surgery
  • GIST profiling of c-KIT for metastatic disease or surgery and PDGFRα for inoperable or metastatic disease
  • Patients with thyroid neoplasm
  • Patients with endometrium neoplasm
  • Patients with cholangiocarcinoma
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Actively Recruiting

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Research Team

G

Giovanni Scambia

CONTACT

C

Camilla Nero

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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