FISH Identified ALK Fusion Positive or Negative Clinical Trial
Official title:
The Study of Exosome EML4-ALK Fusion in NSCLC Clinical Diagnosis and Dynamic Monitoring
The application of ALK inhibitors in the first-line cancer treatment can significantly
increase the PFS and ORR of patients those with EML4-ALK fusion. The contemporary clinical
ALK fusion detection are mainly via FISH and ICH while biopsies are needed. For locations
where are difficult to take biopsies, these routine examinations can hardly been adopted.
Apart from these, part of ALK fusion patients are resistant to ALK inhibitors, also making an
accurate and efficient prognostic indicator for efficacy evaluation and identifying high-risk
recurrent population an urgent priority.
The bilayer membrane structure of exosome helps maintain its internal genetic stability,
making detection of EML4-ALK fusion via plasma exosomes in advanced NSCLC patients a feasible
way, which might provide a non-invasive and more convenient approach for NSCLC diagnosis and
efficacy monitoring. Firstly, this study will evaluate the performance of exosome EML4-ALK
fusion detection in NSCLC diagnosis, which sensitivity and specificity would be compared with
the FDA approved IHC (ALK [D5F3] CDx Assay) test. Subsequently, this study would monitor the
dynamic changes of EML4-ALK fusion in exosome examination diagnosed ALK fusion positive NSCLC
patients both before and after treatment. It aims to prospectively evaluate the potential
value of this approach on efficacy and prognosis prediction in NSCLC therapy and determining
whether exosome ALK fusion could assess the curative effect more accurately than imaging
examination and tumor markers. Thirdly, FISH diagnosed EML4-ALK positive NSCLC patients will
be divided into the positive or negative subgroup according to their post-treatment exosome
ALK fusion expression which were determined at 2-3 months after ALK inhibitor were adopted.
The prognostic value of monitoring exosome EML4-ALK fusion expression is assessed through the
comparison of patients PFS and OS.
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