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

SCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03244904
• Other study ID #: CSWOG01
• Status: Not yet recruiting
• Phase: N/A
• First received: August 5, 2017
• Last updated: August 5, 2017
• Start date: November 2017
• Est. completion date: July 2018

Study information

• Verified date: July 2017
• Source: Fujian Cancer Hospital
• Contact: Gen Lin, MD,PhD
• Phone: 008613313786157
• Email: lingen197505[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 2018
• Est. primary completion date: November 2017
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease Susceptibility
• SCLC
• Small Cell Lung Carcinoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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