NTRK1/2/3 Fusion Gene DetectionNTRKNCT06780384
NTRK 1,2,3 Rearrangements in Patients With Solid Tumors
An observational study of NTRK1/2/3 Fusion Gene Detection, run by Federico Cappuzzo at 2 sites in Italy.
Trial summary
This study aims to evaluate the incidence of NTRK rearrangements in patients with solid tumors in Italy. Additionally, the study seeks to define the correlation between IHC and FISH testing and to simplify the assessment of NTRK rearrangements in patients with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NTRK1/2/3 Fusion Gene Detection
- How many people
- 5,000 participants
- Where
- 2 sitesItaly
- Study dates
- 5 Feb 2020to Aug 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients with solid tumors, irrespective of tumor stage.
Who may be able to join
- Histological diagnosis of any solid cancer
- Availability of tumor tissue for biomarker analyses (at least 5 slides, 4 micron)
- Signed informed consent form
Who cannot join
- No tumor tissue available
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Grisel Maver Militello
Roma, RM, 000144
Istituti Fisioterapici Ospitalieri- Ifo - Istituto Regina Elena
Roma, RM, 00144
About this study
This study aims to evaluate the incidence of NTRK rearrangements in patients with solid tumors in Italy. Additionally, the study seeks to define the correlation between IHC and FISH testing and to simplify the assessment of NTRK rearrangements in patients with solid tumors.
Read the detailed description
Neurotrophic tropomyosin-related kinases (NTRKs, or the commonly used alias TRKs) constitute a receptor tyrosine kinase family of neurotrophin receptors involved in neuronal development, including the growth and function of neuronal synapses and memory development.
NTRK1/2/3 gene fusions have emerged as new targets for cancer therapy as they can be successfully inhibited by targeted kinase inhibitors. Several compounds targeting TRKs are currently being explored in clinical trials and, notably, one of these compounds, larotrectinib (VITRAKVI®), has received accelerated approval by the United States Food and Drug Administration (FDA) for adult and paediatric solid tumours with a NTRK fusion without known resistance mutations. In addition, entrectinib has received breakthrough designation status by the United States FDA for the treatment of cancers types harbouring NTRK fusions. Hence, there is an active interest in clinical oncology for NTRK fusions, which has prompted an urgent need to define the routine diagnostic test to identify gene fusions as a companion diagnostic method to support clinical decision in this context. Irrespective of the method adopted for NTRK detection, high activity of anti-NTRK agents and therefore the necessity to guarantee these agents to all NTRK+ patients, strongly supports a NTRK screening program for patients with cancer.
- Conditions
- NTRK1/2/3 Fusion Gene Detection
- Keywords
- NTRK
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the incidence of NTRK rearrangements in patients with solid tumors in Italy
Tumor tissue slides (4 micron) will be tested for NTRK positivity by means of immunohistochemistry (IHC) and then confirmed by means of fluorescence in-situ hybridization (FISH).
Measured: 36 months
Secondary outcomes (1)
To define incidence of NTRK in different tumor types
The incidence of NTRK gene fusions across different tumor types involves determining how frequently these genetic alterations occur within various malignancies. This process is essential for understanding the potential role of targeted therapies, such as TRK inhibitors, in specific cancers
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start5 Feb 2020
- Primary completionMay 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NTRK1/2/3 Fusion Gene DetectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Federico Cappuzzo
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor-investigator, Federico Cappuzzo, Fondazione Ricerca Traslazionale
- Investigators
- Federico Cappuzzo, PI, Principal investigator, Fondazione FORT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780384
- Sponsor's protocol ID
- NTRK
- Other IDs
- NTRK
- Acronym
- NTRK
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NTRK 1,2,3 Rearrangements in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT06780384
- Acronym / sponsor ID
- NTRK / NTRK
- Conditions
- NTRK1/2/3 Fusion Gene Detection
- Keywords
- NTRK
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Federico CappuzzoUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the incidence of NTRK rearrangements in patients with solid tumors in Italy. Additionally, the study seeks to define the correlation between IHC and FISH testing and to simplify the assessment of NTRK rearrangements in patients with solid tumors.
Detailed description
Neurotrophic tropomyosin-related kinases (NTRKs, or the commonly used alias TRKs) constitute a receptor tyrosine kinase family of neurotrophin receptors involved in neuronal development, including the growth and function of neuronal synapses and memory development.
NTRK1/2/3 gene fusions have emerged as new targets for cancer therapy as they can be successfully inhibited by targeted kinase inhibitors. Several compounds targeting TRKs are currently being explored in clinical trials and, notably, one of these compounds, larotrectinib (VITRAKVI®), has received accelerated approval by the United States Food and Drug Administration (FDA) for adult and paediatric solid tumours with a NTRK fusion without known resistance mutations. In addition, entrectinib has received breakthrough designation status by the United States FDA for the treatment of cancers types harbouring NTRK fusions. Hence, there is an active interest in clinical oncology for NTRK fusions, which has prompted an urgent need to define the routine diagnostic test to identify gene fusions as a companion diagnostic method to support clinical decision in this context. Irrespective of the method adopted for NTRK detection, high activity of anti-NTRK agents and therefore the necessity to guarantee these agents to all NTRK+ patients, strongly supports a NTRK screening program for patients with cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients with solid tumors, irrespective of tumor stage.
Key inclusion criteria (3 listed)
- Histological diagnosis of any solid cancer
- Availability of tumor tissue for biomarker analyses (at least 5 slides, 4 micron)
- Signed informed consent form
Key exclusion criteria (1 listed)
- No tumor tissue available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the incidence of NTRK rearrangements in patients with solid tumors in Italy
Time frame: 36 months
Tumor tissue slides (4 micron) will be tested for NTRK positivity by means of immunohistochemistry (IHC) and then confirmed by means of fluorescence in-situ hybridization (FISH).
1 secondary outcome
To define incidence of NTRK in different tumor types
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federico Cappuzzo, PI principal investigator
Fondazione FORT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NTRK1/2/3 Fusion Gene Detection, run by Federico Cappuzzo at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the incidence of NTRK rearrangements in patients with solid tumors in Italy (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.