Lung Nodule Clinical Trial
Official title:
Detection of Early-stage Lung Cancer by Using Methylation Signatures in Circulating Tumor DNA
NCT number | NCT03685669 |
Other study ID # | KS1811 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2017 |
Est. completion date | December 2019 |
Low-dose computed tomography (LDCT) is recommended for early-stage lung cancer screening. However, it is often difficult to determine indolent lesions from more aggressive tumors without an invasive intervention or prolonged follow-up period. Thus, the main purpose of this study is to develop a non-invasive method to detect lung-cancer specific circulating tumor DNA (ctDNA) in blood, which can greatly improve the specificity of lung cancer early screening.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. 18 years old or above with pulmonary nodule(s) found by LDCT, mean diameter below 30mm. 2. The nodule lesion is peripheral, no signs of lymphatic infiltration or distal metastasis. 3. Fit and consent to surgical resection. 4. Agree to participate in this study and sign informed consents. Exclusion Criteria: 1. Fail to understand or agree to sign informed consent. 2. Patients who did not follow the test plan for timely blood collection or did not cooperate with the study follow-up work. 3. Patients with previous history of cancer and/or cancer treatment such as surgery, radiotherapy, chemotherapy or targeted therapy. 4. Failing to meet the requirements for blood sampling. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Chest Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Chest Hospital | Singlera Genomics Inc. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Noninvasive assisted diagnosis of benign and malignant pulmonary nodules | The biomarker classification model can be used to differentiate patients, who had positive LDCT results, with benign or malignant lung nodules. | 1 year |
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