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

a Prospective Cohort Study for Small Cell Lung Cancer to Identify Susceptibility Gene and Assess DNA Dynamic Change by Next-generation Sequencing

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.

Study Overview

• Status: Unknown
• Conditions: SCLC

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Gen Lin, MD,PhD; Phone Number: 008613313786157; Email: lingen197505@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

SCLC

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
susceptibility gene site of small cell lung cancer	searching susceptibility gene site of small cell lung cancer according to germline mutation data	01.11.2017-31.05.2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
consistency of ctDNA and tDNA sequencing results in patients with SCLC	explore consistency of ctDNA and tDNA sequencing results in patients with ESCLC	01.11.2017-31.05.2018

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitive molecular markers for treating	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	01.11.2017-31.05.2018
molecular classification of SCLC	according to the clinicopathological features of the patients with sclc enrolled , analyzeing molecular classification of SCLC by analyzing mutation types	01.11.2017-31.05.2018

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital
• Investigators: Principal Investigator: Gen Lin, MD,PhD, CSWOG

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: August 5, 2017
• First Submitted That Met QC Criteria: August 5, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): August 10, 2017
• Last Update Submitted That Met QC Criteria: August 5, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: NGS,SCLC, ctDNA
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: CSWOG01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided