Active — Not RecruitingNot Applicable

National Register of Actionable Mutations

Italy2,098 participantsStarted 2018-10-27

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * availabi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

rate of actionable mutations identified with NGS

Timeframe: from October 2018 to study completion, 2 years after the last enrolled patient

Trial details

NCT IDNCT05918666

SponsorFederation of Italian Cooperative Oncology Groups

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-10-27

View on ClinicalTrials.gov More Solid Tumours in Advanced Stages trials