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| ID | Type | Description | Link |
|---|---|---|---|
| MR 0112040319 | Other Identifier | Insitut National des Données de Santé (INDS) |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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This retrospective study has a primary objective to estimate the incidence of NTRK gene fusion depending on the histological diagnosis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects With Locally Advanced/Unresectable or Metastatic Solid Tumors |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at baseline (i.e. at the time of tumor removal) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) in Patients With NRTK Gene Fusion. | PFS is calculated using Kaplan-Meier method, in the population of patients with positive IHC results. | Two years after tumor removal |
Inclusion Criteria:
Exclusion Criteria:
• Subjects who have not yet received or completed at least one systemic anti-cancer therapy for locally advanced/unresectable or metastatic cancer.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Antoine ITALIANO, MD, PhD | a.italiano@bordeaux.unicancer.fr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | Aquitaine | 33000 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Retrospective Cohort | For eligible subject, tumor material will be tested by immunohistochemistry (Pan-Trk ICH testing with mAb EPR17341). Retrospective cohort: Tumor material tested positive will be analyzed by next-generation sequencing to identify NTRK1, NTRK2 or NTRK3 gene fusions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Age and sex were not collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With Locally Advanced/Unresectable or Metastatic Solid Tumors | Tumor material was tested by immunohistochemistry (Pan-Trk ICH testing with mAb EPR17341). Tumor material tested positive were analyzed by next-generation sequencing to identify NTRK1, NTRK2 or NTRK3 gene fusions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age was not collected |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subjects with locally advanced/unresectable or metastatic solid tumors and for whom NGS (new generation sequencing) was performed | Posted | Count of Participants | Participants | at baseline (i.e. at the time of tumor removal) |
|
Retrospective NGS analysis. AE were not collected
AE were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects With Locally Advanced/Unresectable or Metastatic Solid Tumors | Retrospective cohort: For eligible subject, tumor material will be tested by immunohistochemistry (Pan-Trk ICH testing with mAb EPR17341). Tumor material tested positive will be analyzed by next-generation sequencing to identify NTRK1, NTRK2 or NTRK3 gene fusions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Antoine Italiano | Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR | 0556333333 | a.italiano@bordeaux.unicancer.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2021 | Sep 8, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Parrafin embedded tumor material
| at baseline (i.e. at the time of tumor removal) |
| Participants |
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| Sex: Female, Male | Sex was not collected | Sex was not collected | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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NGS / Next-generation sequencing methods : 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. |
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| Secondary | 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 | Participants with positive IHC results | Posted | Count of Participants | Participants | at baseline (i.e. at the time of tumor removal) |
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| Other Pre-specified | Progression-free Survival (PFS) in Patients With NRTK Gene Fusion. | PFS is calculated using Kaplan-Meier method, in the population of patients with positive IHC results. | Only one patient had positive IHC results and had a gene NRTK fusion. | Posted | Median | 95% Confidence Interval | years | Two years after tumor removal |
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