Pulmonary Nodules Clinical Trial
Official title:
A Prospective Cohort Study of Chinese Patients With Pulmonary Nodules: Prediction of Lung Cancer Using Noninvasive Biomarkers
NCT number | NCT04462185 |
Other study ID # | AnchorDx LC023 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2020 |
Est. completion date | December 2024 |
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.
Status | Recruiting |
Enrollment | 3000 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 Years and older, both male and female - Willing and able to provide a written informed consent - Radiologic diagnosis of solid indeterminate pulmonary nodule (5-30 mm) OR semi-solid (mixed density) nodule with solid component of at least 5mm OR non-solid nodule (including pGGO); must be of appropriate size at enrollment, but nodule(s) may have been first identified within 12 months prior. Furthermore, nodule(s) < 5 mm in size may have been first identified greater than 12 months prior to enrollment though it must grow into the appropriate size range (5-30 mm) within 12 months prior to enrollment. If multiple nodules were diagnosed, choose the most representative one with the longest diameter as the target lesion; if two or more nodules are of the same largest size, choose the one with the perpendicular longest diameter - CT scan completed within 3 months prior to enrollment - Agree to tolerate all biospecimen collection as required by protocol - Agree to comply with standard of care follow up visits including clinical exams, diagnostic work-ups, and imaging for 2~3 years from enrollment - Agree to fill out Patient Lung History Questionnaire Exclusion Criteria: - History or previous diagnosis of primary lung cancer, metastatic lung cancer, or any other non-lung cancer within 5 years (exceptions are adequately treated squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast) - Any receipt of cytotoxic agents within the past 6 months - Any symptoms of lung cancer (unexplained weight loss, recent hemoptysis) - Pregnant or lactating women - Underwent invasive biopsy procedures (e.g. bronchoscopies or CT-guided transthoracic biopsies) before enrollment - Receipt of transfusion within 30 days prior to enrollment - Fail to understand or provide a written informed consent |
Country | Name | City | State |
---|---|---|---|
China | Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital | Beijing | |
China | Department of Respiratory Medicine, West China Hospital of Sichuan University | Chengdu | |
China | The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | |
China | Department of Respiratory, Qilu Hospital, Shandong University | Jinan | |
China | Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University | Shanghai | |
China | Department of Respiratory and Critical Care Medicine, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan |
Lead Sponsor | Collaborator |
---|---|
AnchorDx Medical Co., Ltd. | Beijing Chao Yang Hospital, Johnson & Johnson (China) Investment Ltd., Qilu Hospital of Shandong University, Shanghai Zhongshan Hospital, The First Affiliated Hospital of Guangzhou Medical University, Tongji Hospital, West China Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The changes in genomic landscape related to progression from Stage 0 to Stage I lung cancer that could be utilized for early lung cancer diagnosis and intervention. | The transcriptome of benign versus malignant by using RNA sequencing. The cfDNA in blood samples collected from patients with pulmonary nodules. | 3 Years | |
Secondary | The biomarker changes in nasal epithelium and matching blood and tissue samples so as to validate molecular tests using nasal epithelium to predict lung cancer. | The biomarker change in nasal epithelium to predict lung cancer. | 3 Years | |
Secondary | The individual or combinations of clinical, molecular, and imaging features can reliably identify individuals with indeterminate lung nodules 5-30 mm who have lung cancer | The individual or combination of clinical, molecular, and imaging features can reliably identify individuals who have lung cancer | 3 Years |
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