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National Register of Actionable Mutations (RATIONAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05918666
Recruitment Status : Recruiting
First Posted : June 26, 2023
Last Update Posted : June 26, 2023
Sponsor:
Collaborators:
Roche Pharma AG
AstraZeneca
Bayer
Bristol-Myers Squibb
Janssen, LP
Takeda
Amgen
Daiichi Sankyo
Eli Lilly and Company
Novartis
Clinical Research Technology S.r.l.
Information provided by (Responsible Party):
Federation of Italian Cooperative Oncology Groups

Study Description
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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.


Condition or disease
Solid Tumours in Advanced Stages

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: National Register of Actionable Mutations - Rational Study
Actual Study Start Date : October 27, 2018
Estimated Primary Completion Date : October 27, 2026
Estimated Study Completion Date : October 27, 2026
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. rate of actionable mutations identified with NGS [ Time Frame: from October 2018 to study completion, 2 years after the last enrolled patient ]
    information on somatic mutations obtained by analysis of neoplastic tissue samples and/or liquid biopsy (circulating tumor DNA extracted from the patient's plasma).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with solid tumors in advanced stage of disease
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05918666


Contacts
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Contact: Nicola Normanno, MD 081.5903111 n.normanno@istitutotumori.na.it

Locations
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Sponsors and Collaborators
Federation of Italian Cooperative Oncology Groups
Roche Pharma AG
AstraZeneca
Bayer
Bristol-Myers Squibb
Janssen, LP
Takeda
Amgen
Daiichi Sankyo
Eli Lilly and Company
Novartis
Clinical Research Technology S.r.l.
Investigators
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Principal Investigator: Nicola Normanno INT- IRCCS Fondazione Pascale, Napoli
More Information
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Publications:

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Responsible Party: Federation of Italian Cooperative Oncology Groups
ClinicalTrials.gov Identifier: NCT05918666    
Other Study ID Numbers: Rational study
First Posted: June 26, 2023    Key Record Dates
Last Update Posted: June 26, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No