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National Register of Actionable Mutations
National Register of Actionable Mutations

NCT05918666

Active Not RecruitingN/A

Sponsor: Federation of Italian Cooperative Oncology Groups

Conditions: Solid Tumours in Advanced Stages

Countries: Italy

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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.
Locations (43)
  • Ancona, Italy
  • Arezzo, Italy
  • Avellino, Italy
  • Aviano, Italy
  • Bari, Italy
  • Bergamo, Italy
  • Bergamo, Italy
  • Brindisi, Italy
  • Catania, Italy
  • Catania, Italy
  • Florence, Italy
  • Genova, Italy
  • Meldola, Italy
  • Messina, Italy
  • Messina, Italy
  • Milan, Italy
  • Milan, Italy
  • Milan, Italy
  • Milan, Italy
  • Naples, Italy
  • Naples, Italy
  • Naples, Italy
  • Naples, Italy
  • Negrar, Italy
  • Padova, Italy
  • Palermo, Italy
  • Pavia, Italy
  • Perugia, Italy
  • Pisa, Italy
  • Reggio Emilia, Italy
  • + 13 more on CT.gov