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Trial Title:
Mutational Oncology in Clinical Practice
NCT ID:
NCT06020625
Condition:
Genome Instability
Genetic Predisposition to Disease
Gene Rearrangement
Conditions: Official terms:
Genetic Predisposition to Disease
Genomic Instability
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
Diagnostic Test
Description:
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.
Arm group label:
Interventional
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Rome
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giovanni Scambia
Email:
giovanni.scambia@policlinicogemelli.it
Contact backup:
Last name:
Camilla Nero
Email:
camilla.nero@policlinicogemelli.it
Start date:
January 1, 2022
Completion date:
January 2032
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06020625
