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Clinical Trial Summary

The broad goals of this study is to identify changes in genomic landscape during transition from stage 0 to stage 1 lung cancer. This study intends to determine whether diagnostic biomarkers measured in minimally invasive biospecimens are able to correlate molecular, clinical and imaging features to distinguish malignant from benign pulmonary nodules. The diagnostic markers once validated can be used as broad screening tools for lung cancer.


Clinical Trial Description

The four-year study aims to recruit 3000 patients (1500 GGO and 1500 solid / semi solid nodules) in the study based on qualifying for a lung cancer screening CT or by routine CT chest with the observation of a lung nodule between 5-30mm diameter. These patients will be followed for 2~3 years and be managed according to institutional standard of care. This may involve the Chinese Thoracic Society guideline or Fleischner criteria (either 2013 or 2017 guidelines). The clinical data, CT imaging and biospecimens will be collected during each visit. Once a patient undergoes surgery, tissue samples (FFPE) from surgery will also be collected. The gold standard for lung cancer diagnosis will be the results of bronchoscopic biopsy of lung or lymph nodes, percutaneous biopsy of lung or other organ sites, surgical biopsy or resection, or a minimum follow-up of 2 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04462185
Study type Observational
Source AnchorDx Medical Co., Ltd.
Contact Bo WANG
Phone +86-15920405979
Email bo_wang@anchordx.com
Status Recruiting
Phase
Start date July 1, 2020
Completion date December 2024

See also
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Active, not recruiting NCT05091437 - DOuBLED - Doubling Outcomes by Lung Cancer Early Diagnosis