Status:
UNKNOWN
A Prospective Cohort Study of Chinese Patients With Pulmonary Nodules: Prediction of Lung Cancer Using Noninvasive Biomarkers
Lead Sponsor:
AnchorDx Medical Co., Ltd.
Collaborating Sponsors:
The First Affiliated Hospital of Guangzhou Medical University
Tongji Hospital
Conditions:
Pulmonary Nodules
Eligibility:
All Genders
18+ years
Brief 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...
Detailed 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 observa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT04462185
Start Date
July 1 2020
End Date
December 1 2024
Last Update
May 24 2023
Active Locations (6)
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1
Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital
Beijing, China
2
Department of Respiratory Medicine, West China Hospital of Sichuan University
Chengdu, China
3
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
4
Department of Respiratory, Qilu Hospital, Shandong University
Jinan, China