Metastatic Solid TumorsNTRKNCT04010240
A Retrospective Study to Determine the Incidence of NTRK Fusions. NTRK Study
An observational study of Metastatic Solid Tumors, run by Institut Bergonié at 1 site in France.
Trial summary
This retrospective study has a primary objective to estimate the incidence of NTRK gene fusion depending on the histological diagnosis. Read more about this study
- Who is it for?
- Ages 1 month to 100 years
- Conditions the study is for
- Metastatic Solid Tumors
- How many people
- 3,820 participants
- Where
- 1 siteFrance
- Study dates
- 23 Dec 2015to 31 Dec 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 month to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The cohort will included both adult and pediatric patients with metastatic solid tumors, who have received at least one systemic anti-cancer therapy for advanced disease and for which there is available both outcome information and tumor material.
Who may be able to join
- Age ≥ 1 month.
- Subject has/had a histologically or cytologically confirmed diagnosis of solid tumor including but not exclusively: soft tissue sarcoma, BRAF wild type melanoma, KRAS wild-type colorectal cancer, central nervous system, EGFR-wild type non-small cell lung cancer.
- Subject has locally advanced/unresectable or metastatic disease.
- Subject has received at least one systemic anti-cancer therapy for locally advanced/unresectable or metastatic disease for which there is available outcome information in terms of PFS, or the latter can be estimated based on the subject's records.
- Subject has tumor material available for immunoscreening (IHC for NTRK gene fusions).
- Written and voluntary informed consent understood, signed and dated, or a waiver of consent is granted according to French régulations.
Who cannot join
- Subjects who have not yet received or completed at least one systemic anti-cancer therapy for locally advanced/unresectable or metastatic cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Determine the Incidence of NTRK Fusions in Subjects With Locally Advanced/Unresectable or Metastatic Solid Tumors With NTRK Fusions and Related Treatment Outcomes.
This retrospective study has a primary objective to estimate the incidence of NTRK gene fusion depending on the histological diagnosis.
Read the detailed description
This retrospective study has a primary objective to estimate the incidence of NTRK gene fusion depending on the histological diagnosis. The tropomyosin receptor kinase (Trk) receptor family comprises 3 transmembrane proteins referred to as Trk A, B and C (TrkA, TrkB and TrkC) receptors that are encoded by the NTRK1, NTRK2 and NTRK3 genes, respectively. These receptor tyrosine kinases are expressed in human neuronal tissue and play an essential role in the physiology of development and function of the nervous system through activation by neurotrophins. Gene fusions involving NTRK genes lead to transcription of chimeric Trk proteins with constitutively activated or overexpressed kinase function conferring oncogenic potential. These genetic abnormalities have recently emerged as targets for cancer therapy, because novel compounds have been developed that are selective inhibitors of the constitutively active rearranged proteins. Developments in this field are being aided by next generation sequencing methods as tools for unbiased gene fusions discovery. However, the incidence of NTRK aberrations in solid tumors is unknown as well as the natural history of NTRK-rearranged tumors This study will provide better knowledge of NTRK gene fusion incidence to allow recommendations for pathological diagnosis.
Subjects who are tested positive by Immunohistochemistry (IHC : Pan-Trk IHC testing with mAb EPR17341) will be the subject of molecular assays such as next-generation sequencing (Archer Dx fusion assay) of tumor material [parrafin embedded material]), so that tumor harboring NTRK1, NTRK2 or NTRK3 gene fusions, is identified properly.
- Conditions
- Metastatic Solid Tumors
- Being tested
- No intervention (this is a retrospective cohort study)
- Keywords
- Solid tumor, Metastatic, NTRK
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (this is a retrospective cohort study)Other
No intervention (this is a retrospective cohort study) aimed at describing tumour samples. No treatment/intervention is being tested.
| Study group | Role | What they receive |
|---|---|---|
| Subjects With Locally Advanced/Unresectable or Metastatic Solid Tumors | Not described Receives: Other: No intervention (this is a retrospective cohort study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Participants With NRTK Fusions Among Participants Analyzed by NGS (Next-generation Sequencing).
A participant with NRTK fusion is defined as a participant with a tumor harboring NTRK1, NTRK2 or NTRK3 gene fusions, based on NGS (Next-generation sequencing methods).
NGS (Next-generation sequencing methods) method: DNA and RNA were extracted from tumor tissue according to standard procedures. All samples had their RNA analyzed with Archer or full RNA sequencing to assess specific novel NTRK1, 2, and 3 rearrangements for the production of NTRK fusion transcripts. Alternatively, DNA was analyzed by using an hybrid-capture based NGS assay as previously described.
Measured: at baseline (i.e. at the time of tumor removal)
Secondary outcomes (1)
Count of Participants With NRTK Fusions Among Participants With With Positive Immunohistochemistry (IHC)
A participant with NRTK fusion is defined as a participant with a tumor harboring NTRK1, NTRK2 or NTRK3 gene fusions, based on Immunohistochemistry (IHC).
Immunohistochemistry (IHC) mehtod : Pan-TRK: rabbit monoclonal antibody, clone C17F1, Cell signaling dilution 1/50°. Automate Benchmark: ULTRA Ventana, CC1 64', incubation 52', revelation kit Optiview
Measured: at baseline (i.e. at the time of tumor removal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start23 Dec 2015
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Solid TumorsStudies 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
- Retrospective
- Enrolment
- 3,820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Antoine ITALIANO, MD, PhD, Principal investigator, a.italiano@bordeaux.unicancer.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010240
- Sponsor's protocol ID
- IB2015-NTRK
- Other IDs
- MR 0112040319
- Acronym
- NTRK
- Status last verified
- Sep 2025
- First submitted
- 3 Jul 2019
- Last updated
- 16 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Incidence of NTRK Fusions in Subjects With Locally Advanced/Unresectable or Metastatic Solid Tumors With NTRK Fusions and Related Treatment Outcomes.
- ClinicalTrials.gov ID
- NCT04010240
- Acronym / sponsor ID
- NTRK / IB2015-NTRK
- Conditions
- Metastatic Solid Tumors
- Keywords
- Solid tumor, Metastatic, NTRK
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,820 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 23 Dec 2015 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Posted 16 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective study has a primary objective to estimate the incidence of NTRK gene fusion depending on the histological diagnosis.
Detailed description
This retrospective study has a primary objective to estimate the incidence of NTRK gene fusion depending on the histological diagnosis. The tropomyosin receptor kinase (Trk) receptor family comprises 3 transmembrane proteins referred to as Trk A, B and C (TrkA, TrkB and TrkC) receptors that are encoded by the NTRK1, NTRK2 and NTRK3 genes, respectively. These receptor tyrosine kinases are expressed in human neuronal tissue and play an essential role in the physiology of development and function of the nervous system through activation by neurotrophins. Gene fusions involving NTRK genes lead to transcription of chimeric Trk proteins with constitutively activated or overexpressed kinase function conferring oncogenic potential. These genetic abnormalities have recently emerged as targets for cancer therapy, because novel compounds have been developed that are selective inhibitors of the constitutively active rearranged proteins. Developments in this field are being aided by next generation sequencing methods as tools for unbiased gene fusions discovery. However, the incidence of NTRK aberrations in solid tumors is unknown as well as the natural history of NTRK-rearranged tumors This study will provide better knowledge of NTRK gene fusion incidence to allow recommendations for pathological diagnosis.
Subjects who are tested positive by Immunohistochemistry (IHC : Pan-Trk IHC testing with mAb EPR17341) will be the subject of molecular assays such as next-generation sequencing (Archer Dx fusion assay) of tumor material [parrafin embedded material]), so that tumor harboring NTRK1, NTRK2 or NTRK3 gene fusions, is identified properly.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects With Locally Advanced/Unresectable or Metastatic Solid Tumors | – | Other: No intervention (this is a retrospective cohort study) |
Who may qualify
- Ages
- 1 month to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The cohort will included both adult and pediatric patients with metastatic solid tumors, who have received at least one systemic anti-cancer therapy for advanced disease and for which there is available both outcome information and tumor material.
Key inclusion criteria (6 listed)
- Age ≥ 1 month.
- Subject has/had a histologically or cytologically confirmed diagnosis of solid tumor including but not exclusively: soft tissue sarcoma, BRAF wild type melanoma, KRAS wild-type colorectal cancer, central nervous system, EGFR-wild type non-small cell lung cancer.
- Subject has locally advanced/unresectable or metastatic disease.
- Subject has received at least one systemic anti-cancer therapy for locally advanced/unresectable or metastatic disease for which there is available outcome information in terms of PFS, or the latter can be estimated based on the subject's records.
- Subject has tumor material available for immunoscreening (IHC for NTRK gene fusions).
Key exclusion criteria (1 listed)
- Subjects who have not yet received or completed at least one systemic anti-cancer therapy for locally advanced/unresectable or metastatic cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (this is a retrospective cohort study)No intervention (this is a retrospective cohort study) aimed at describing tumour samples. No treatment/intervention is being tested. | Other | Subjects With Locally Advanced/Unresectable or Metastatic Solid Tumors |
Primary outcome
Count of Participants With NRTK Fusions Among Participants Analyzed by NGS (Next-generation Sequencing).
Time frame: at baseline (i.e. at the time of tumor removal)
A participant with NRTK fusion is defined as a participant with a tumor harboring NTRK1, NTRK2 or NTRK3 gene fusions, based on NGS (Next-generation sequencing methods). NGS (Next-generation sequencing methods) method: DNA and RNA were extracted from tumor tissue according to standard procedures. All samples had their RNA analyzed with Archer or full RNA sequencing to assess specific novel NTRK1, 2, and 3 rearrangements for the production of NTRK fusion transcripts. Alternatively, DNA was analyzed by using an hybrid-capture based NGS assay as previously described.
1 secondary outcome
Count of Participants With NRTK Fusions Among Participants With With Positive Immunohistochemistry (IHC)
Time frame: at baseline (i.e. at the time of tumor removal)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Antoine ITALIANO, MD, PhD principal investigator
a.italiano@bordeaux.unicancer.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Solid Tumors, run by Institut Bergonié at 1 site in France.
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 6 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: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Yes. Results are posted in the registry (first posted 16 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Count of Participants With NRTK Fusions Among Participants Analyzed by NGS (Next-generation Sequencing). (time frame: at baseline (i.e. at the time of tumor removal)). 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 16 Oct 2025.