Application of ctDNA in the Evaluation of Curative Effect and Prognosis of SCLC Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the application value of circulating tumor DNA(ctDNA) with efficacy evaluation and prognostic assessment in patients with unresectable SCLC, who were receiving radiotherapy and chemotherapy treatment.

Detailed Description
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According to each point in time of ctDNA, to analyze the dynamic changes of tumor burden and clonal subtypes which to evaluate the application value of ctDNA in curative efficacy evaluation. Compare the two time points before and after radiotherapy and chemotherapy treatment of the cell free DNA (cfDNA) concentration and tumor burden, analysis the correlation between the changes and prognosis.

Official Title
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Application of Circulating Tumor (ctDNA) in the Evaluation of Curative Effect and Prognosis of Small Cell Lung Cancer (SCLC) Patients

Conditions
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Small Cell Lung Cancer Extensive Stage

Intervention / Treatment
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* Other: Observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent； Newly diagnosed and histological or cytological confirmed extensive stage small cell lung cancer; All indicators has confirmed and allow to receive radiotherapy and chemotherapy; Follow-up can be carried out and the peripheral blood samples can be collected; Cooperate with the provision of clinical pathological data required by the research. Exclusion Criteria: Patients have other primary cancers; Patients unable to cooperate with the study for follow-up according to the determined clinical follow-up cycle; Unable to accept the judgment of curative effect evaluation by the designated methods such as CT.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observation|observe the association of ctDNA with efficacy of treatment|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ctDNA mutation profile at baseline | ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance | before treatment ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks) | 
| the evolution of ctDNA mutation profile during treatment | ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance | After the first cycle of first line treatment upon physicians' request, ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks) | 
| the evolution of ctDNA mutation profile during treatment | ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance | After finished the first line treatment, ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free of survival | From the first line treatment to the time of disease progression (through study completion, an average of 5 months) |