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

F

Fujian Provincial Cancer Hospital

Status

Unknown

Conditions

SCLC

Study type

Observational

Funder types

Other

Identifiers

NCT03244904
CSWOG01

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

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Central trial contact

Gen Lin, MD,PhD

Data sourced from clinicaltrials.gov

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