Next-generation Sequencing of Small Cell Lung Cancer to Identify Susceptibility Gene and to Assess Treatment

• Conditions: SCLC

• Registration Number: NCT03244904
• Lead Sponsor: Fujian Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-08-05
• Study First Submitted QC: 2017-08-05
• Last Update Submitted: 2017-08-05
• Study First Posted: 2017-08-10
• Last Update Posted: 2017-08-10
• Study Start: 2017-11
• Primary Completion: 2017-11
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients must understand the rigors of the study and provide written informed consent and HIPAA authorization prior to initiation of any study procedures
• Life expectancy > 10 months
• Karnofsky Performance Status ≥ 70
• Diagnosis of histological or cytologically confirmed SCLC,
• Age ≥ 18 years
• 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.

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Exclusion Criteria

• Poor compliance, reluctant to undergo research medication, or follow-up.
• Tumor inaccessible for biopsy
• 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.
• It has a history of other cancers, unless the cancer is completely relieved and has not been treated for more than 3 years.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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