Next-generation Sequencing of Small Cell Lung Cancer to Identify Susceptibility Gene and to Assess Treatment
Study Details
Study Description
Brief Summary
Participants will be consented into the study after they are found to meet the study inclusion criteria. The clinical staff will schedule a tissue biopsy and a blood draw for the participant to give NGS(Next-generation Sequencing).One is according to the germline mutation data to screen susceptible gene in SCLC(Small Cell Lung Cancer); two is to explore the extensive consistency detection of blood and tissues in patients with SCLC gene mutation information; three is to conduct dynamic monitoring of blood ctDNA(circulating tumor DNA) in patients with SCLC during treatment, by changing the types of mutations / abundance (for example: the clonal evolution of typical samples analysis) and change of tumor load, , investigating the patients treatment effect , for the significant change of mutations, to study whether it can be used as molecular marker; four is to analyze of the molecular typing of SCLC, according to the clinical and pathological features of patients.
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Study Design
Outcome Measures
Primary Outcome Measures
- susceptibility gene site of small cell lung cancer [01.11.2017-31.05.2018]
searching susceptibility gene site of small cell lung cancer according to germline mutation data
Secondary Outcome Measures
- consistency of ctDNA and tDNA sequencing results in patients with SCLC [01.11.2017-31.05.2018]
explore consistency of ctDNA and tDNA sequencing results in patients with ESCLC
Other Outcome Measures
- sensitive molecular markers for treating [01.11.2017-31.05.2018]
during treatment of blood ctDNA for dynamic monitoring, through the mutation type/abundance changes (for example, a typical sample of clonal evolution analysis) and tumor mutation load change, studying whether significant changes of mutations can be used as molecular markers of SCLC
- molecular classification of SCLC [01.11.2017-31.05.2018]
according to the clinicopathological features of the patients with sclc enrolled , analyzeing molecular classification of SCLC by analyzing mutation types
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients must understand the rigors of the study and provide written informed consent and HIPAA authorization prior to initiation of any study procedures
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Life expectancy > 10 months
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Karnofsky Performance Status ≥ 70
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Diagnosis of histological or cytologically confirmed SCLC,
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Age ≥ 18 years
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Good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy.
Exclusion Criteria:
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Poor compliance, reluctant to undergo research medication, or follow-up.
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Tumor inaccessible for biopsy
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It is currently included in clinical trials of other drugs, or at the same time, into other medical studies that are considered incompatible with the study.
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It has a history of other cancers, unless the cancer is completely relieved and has not been treated for more than 3 years.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fujian Cancer Hospital
Investigators
- Principal Investigator: Gen Lin, MD,PhD, CSWOG
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSWOG01