- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05793281
An Observational Study to Learn More About NTRK Gene Fusion Positive in Solid Tumor in Japan
A Retrospective Observational Study to Investigate the Prevalence of NTRK Gene Fusion Positive in Solid Tumor in Japan
This is an observational study in which data from the past of people with solid tumors harboring an NTRK gene fusion in Japan are studied. In observational studies, only observations are made without specified advice or interventions.
Advanced or recurrent solid tumor harboring an NTRK gene fusion is a rare type of solid cancer caused by specific changes in the genes called NTRK gene fusion, and which has spread to nearby tissues and/or lymph nodes or has returned. Due to this change in the gene, an altered protein known as a TRK fusion protein is made, which can cause cancer cells to grow and survive.
The main purpose of this study is to learn more about NTRK gene fusion in people in Japan. To do this, researchers will collect information on the number or percentage of Japanese people with NTRK gene fusion in any solid tumor.
The data will come from the national database called C-CAT. They will cover the period from June 2019 until January 2023.
Besides this data collection, no further tests or examinations are planned, and no visits are required in this study.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Multiple Locations, Japan
- Many Locations
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with any solid tumor and genome profiling results
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients with solid tumor and genome profiling results
Retrospective data analysis, the dataset for this study will be extracted from the C-CAT database.
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Retrospective data analysis, the dataset for this study will be extracted from the C-CAT database.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence of patients with NTRK gene fusions by patient characteristic categories, such as tumor types
Time Frame: Retrospective data analysis from June 2019 to the latest data available (planned end of February 2023)
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Retrospective data analysis from June 2019 to the latest data available (planned end of February 2023)
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Distribution of cancer types in patients with NTRK fusion positive among all, adult and pediatric
Time Frame: Retrospective data analysis from June 2019 to the latest data available (planned end of February 2023)
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Retrospective data analysis from June 2019 to the latest data available (planned end of February 2023)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22415
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion
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Jiangsu vcare pharmaceutical technology co., LTDCompletedLocally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene FusionChina
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BayerRecruitingLocally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene FusionUnited States, Austria, Denmark, Germany, Italy, Norway, Spain, United Kingdom, Brazil, Russian Federation, Switzerland, Taiwan, Canada, China, Australia, Greece, Belgium, Sweden, Korea, Republic of, France, Argentina, Finland, Ireland and more
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BayerRecruitingAdvanced or Recurrent Solid Tumor Harboring an NTRK Gene FusionJapan
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Jiangsu Simcere Pharmaceutical Co., Ltd.RecruitingAdvanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene FusionChina
-
BayerCompletedLocally Advanced or Metastatic Infantile Fibrosarcoma Harboring an NTRK Gene Fusion | Infantile FibrosarcomaFrance
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Beijing InnoCare Pharma Tech Co., Ltd.RecruitingAdvanced Solid Tumors Harboring NTRK Fusion | Primary Central Nervous System Tumors Harboring NTRK FusionChina
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National Cancer Center, JapanEisai Co., Ltd.Active, not recruitingAdvanced or Recurrent Solid Tumors | FGFR Gene AlterationsJapan
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University Health Network, TorontoBayer; AstraZeneca; Amgen; Applied Health Research Centre; Takeda Canada, Inc.; Programs...RecruitingCancer | Malignancies Multiple | Malignant Solid Tumor | Cancer, Therapy-Related | Molecular Sequence Variation | Genetic Alteration | Gene Fusion | Receptor Tyrosine Kinase Gene Mutation | RTK Family Gene Mutation | Ras (Kras or Nras) Gene MutationCanada
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PlexxikonTerminatedSolid Tumor | Tenosynovial Giant Cell Tumor | Tumors of Any Histology With Activating Trk (NTRK) Point or NTRK Fusion MutationsUnited States
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Novartis PharmaceuticalsRecruitingBRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid TumorJapan
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BayerCompletedDiabetes Mellitus | Metabolic DiseaseIndia
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BayerCompletedThromboembolismSpain
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BayerCompleted
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Far Eastern Memorial HospitalCompletedOutcome of Endometrial CancerTaiwan
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