Small Cell Lung Cancer Extensive Stage
Conditions
Brief summary
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
1. 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. 2. 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.
Interventions
OTHERObservation
observe the association of ctDNA with efficacy of treatment
Sponsors
Xiangya Hospital of Central South University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ctDNA mutation profile at baseline | before treatment ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks) | ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance |
| the evolution of ctDNA mutation profile during treatment | After the first cycle of first line treatment upon physicians' request, ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks) | ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | From the first line treatment to the time of disease progression (through study completion, an average of 5 months) | Progression free of survival |
Contacts
Primary ContactDeng
Outcome results
None listed