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Creating a national register of actionable mutations for advanced solid tumors

National Register of Actionable Mutations - Rational Study

Observational Federation of Italian Cooperative Oncology Groups · NCT05918666

This study is trying to create a national database of useful genetic changes in advanced solid tumors to help patients in Italy access better targeted treatments.

Quick facts

Study typeObservational
Enrollment3000 (estimated)
Ages18 Years and up
SexAll
SponsorFederation of Italian Cooperative Oncology Groups Academic / other
Locations42 sites (Ancona and 41 other locations)
Trial IDNCT05918666 on ClinicalTrials.gov

What this trial studies

This observational study aims to establish a national network for precision medicine in Italy, focusing on patients with advanced solid tumors. It will create a register of actionable mutations by collecting clinical data retrospectively and prospectively from patients undergoing genetic screening. The study will assess the frequency of these mutations and their correlation with clinical characteristics, as well as track the efficacy and toxicity of targeted therapies based on identified mutations. The goal is to enhance access to innovative treatments for patients suffering from these conditions.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with advanced-stage solid tumors who have undergone or will undergo genetic characterization.

Not a fit: Patients with early-stage tumors or those who do not meet the eligibility criteria for genetic screening may not benefit from this study.

Why it matters

Potential benefit: If successful, this initiative could significantly improve treatment options for patients with advanced solid tumors by facilitating access to targeted therapies.

How similar studies have performed: Other studies have shown success in utilizing genomic screening to guide treatment decisions in cancer, indicating a promising approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Ancona and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid Tumours in Advanced Stages
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.