Official Title
National Register of Actionable Mutations - Rational Study
Brief Title
National Register of Actionable Mutations
Protocol ID
NCT05918666
Lead Sponsor
Federation of Italian Cooperative Oncology Groups
Brief Summary
The goal of this observational study is the creation of a national network of precision
medicine, which allows to increase, for Italian patients suffering from solid tumors, the
possibility of access to more innovative therapies and to collect retrospectively their
clinical data.
For this purpose, a national register of actionable mutations in patients with solid
tumors in advanced stage of disease will be created in which various individual, local
and regional initiatives of genomic screening of cancer could merge.
Detailed Description
The primary objective of this observational study is to describe the frequency of
actionable mutations in patients with solid tumors in advanced stage, receiving a
genetic-molecular characterization with high throughput methods.
The secondary objectives are:
1. assess the correlation between genetic alterations and clinical and pathological
characteristics of enrolled patients (gender, age, histological variant, location
and extent of neoplasm, comorbidity, familiarity for neoplasms);
2. describe, where possible, any variation in the molecular profile for patients who
are subjected to genetic screening analysis at different stages of the disease.
3. record retrospectively clinical efficacy and toxicity data when patients were
treated with a target therapy based on the detected molecular alterations.
The national register of actionable mutations will be created collecting the following
data:
1. Data extracted retrospectively from medical records of patients that have received
during the study period a test with high-throughput technologies for the molecular
characterization of their tumor, either by clinical routine or for research
purposes.
2. Data collected prospectively from analysis of biological samples (FFPE and biopsy
liquid) of patients that meet the elibility criteria and that perform the
molecular-genetic screening using Foundation Medicine services or in selected
italian laboratories.
3. Clinical data collected retrospectively (RR, DOR, PFS, OS, toxicity), in case where
the patients are treated with a target therapy, based on the highlighted molecular
alterations and on the choice of the clinician.
Only samples already available for clinical practice will be used in the study.
The register will be limited to collecting information on molecular alterations that can
then be used for the insertion of patients in clinical studies already active, for the
design of new studies proposed by members of the Steering Committee or of the
participating sites, or for treatment with other modality.
Study Period
-
Enrollment Count
2,098 participants
Eligibility Criteria
General Inclusion Criteria for all patients:
- Age >18 years old
- Life expectancy 6 months
- ECOG performance status 2
- Diagnosis of malignant solid tumor, in advanced stage
- Informed consent to data registration and for privacy purposes
Additional inclusion criteria for patients that have already carried out a genetic
characterisation extended by high throughput methods:
● Availability of the result of the broad spectrum analysis of genetic alterations
carried out with high throughput methods on biological samples
Additional inclusion criteria for patients that perform the molecular-genetic screening
using Foundation Medicine services or in selected italian laboratories:
- one of the following criteria:
- Patients diagnosed with NSCLC not squamous, not pretreated;
- Patients with biliary tract, pancreatic, esophagus, stomach, thymus, CNS,
nasopharynx, salivary glands, endometrium and urothelium cancers;
- Patients with any disease (including NSCLC) who are progressing disease after
treatment with molecular target drugs. For these patients is the availability
of a post- treatment biological sample is necessary;
- Patients with cancer of unknown primary (CUP);
- Young patients (<40 years) or patients who have exhausted standard lines of
therapy, with any advanced/metastatic tumor which, in the opinion of the
investigator, may benefit from a genetic-molecular characterization at broad
spectrum aimed at a treatment with molecular target therapies.
- availability of biological material for testing.
- informed consent for testing.
Additional exclusion criteria for patients that perform the molecular-genetic screening
using Foundation Medicine services or in selected italian laboratories:
● patients who have already received NGS or other high throughput in the same stage of
disease.
Filters
Solid Tumours in Advanced Stages
ACTIVE_NOT_RECRUITING
ADULT
OLDER_ADULT