NTRK Tissue Study
Research type
Research Study
Full title
Evaluation of the Frequency and Characterization of Abnormalities in NTRK Genes in Solid Tumors and Hematologic Malignancies
IRAS ID
234708
Contact name
Julia Chisholm
Contact email
Sponsor organisation
LOXO Oncology Inc.
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The characterization of cancer genomes has identified new molecular abnormalities implicated in the pathogenesis of malignancy. Abnormalities of neurotrophic tropomyosin receptor kinase (NTRK) genes, particularly gene rearrangements, have recently become the basis of clinical trials examining the role of novel agents inhibiting the biological effects of these molecular alterations.
A detailed review of the literature indicates that NTRK gene abnormalities occur as low frequency events, albeit across multiple tumour histologies. However, this low frequency of detection may reflect (until recently) a lack of interest given the few therapy options available that targets these molecular abnormalities.
This protocol is laboratory-only and will attempt to improve understanding of the distribution, frequency and characterization of abnormalities of the NTRK genes.
The study may be offered to any patient diagnosed with a metastatic solid tumor cancer or advanced hematologic malignancy. Patients will be consented to allow archived tumor tissue to be tested.
All tests will be performed in a CLIA / GCLP or similarly certified laboratory that has been validated by the Sponsor for detection of TRK expression by immunohistochemistry and/or detection of abnormalities of NTRK genes by next generation sequencing.
It is anticipated that the study will be open for two years and results will be evaluated using descriptive statistics.
The study is funded by LOXO oncology.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
17/EM/0460
Date of REC Opinion
15 Feb 2018
REC opinion
Further Information Favourable Opinion