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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03244904
Enrollment
80
Registered
2017-08-10
Start date
2017-11-30
Completion date
2018-07-31
Last updated
2017-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SCLC

Keywords

NGS,SCLC, ctDNA

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.

Interventions

None listed

Sponsors

Fujian Cancer Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
susceptibility gene site of small cell lung cancer01.11.2017-31.05.2018searching susceptibility gene site of small cell lung cancer according to germline mutation data

Secondary

MeasureTime frameDescription
consistency of ctDNA and tDNA sequencing results in patients with SCLC01.11.2017-31.05.2018explore consistency of ctDNA and tDNA sequencing results in patients with ESCLC

Other

MeasureTime frameDescription
sensitive molecular markers for treating01.11.2017-31.05.2018during 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
molecular classification of SCLC01.11.2017-31.05.2018according to the clinicopathological features of the patients with sclc enrolled , analyzeing molecular classification of SCLC by analyzing mutation types

Contacts

Primary ContactGen Lin, MD,PhD
lingen197505@163.com008613313786157

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026