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

NCT03244904 | Unknown

• 1 other identifier: CSWOG01
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

SCLC

Keywords

NGS,SCLC, ctDNA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• consistency of ctDNA and tDNA sequencing results in patients with SCLC

  01.11.2017-31.05.2018

Other Outcomes (2)

• sensitive molecular markers for treating

  01.11.2017-31.05.2018

• molecular classification of SCLC

  01.11.2017-31.05.2018

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SCLC

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Officials

• Gen Lin, MD,PhD

  CSWOG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gen Lin, MD,PhD

CONTACT

008613313786157; lingen197505@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2017
• First Posted: August 10, 2017
• Study Start: November 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: July 1, 2018
• Last Updated: August 10, 2017

Record last verified: 2017-07