Small Cell Lung Cancer Extensive Stage Clinical Trial
Official title:
Application of Circulating Tumor (ctDNA) in the Evaluation of Curative Effect and Prognosis of Small Cell Lung Cancer (SCLC) Patients
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Xiangya Hospital of Central South University |
Mohan S, Foy V, Ayub M, Leong HS, Schofield P, Sahoo S, Descamps T, Kilerci B, Smith NK, Carter M, Priest L, Zhou C, Carr TH, Miller C, Faivre-Finn C, Blackhall F, Rothwell DG, Dive C, Brady G. Profiling of Circulating Free DNA Using Targeted and Genome-wide Sequencing in Patients with SCLC. J Thorac Oncol. 2020 Feb;15(2):216-230. doi: 10.1016/j.jtho.2019.10.007. Epub 2019 Oct 16. — View Citation
Nong J, Gong Y, Guan Y, Yi X, Yi Y, Chang L, Yang L, Lv J, Guo Z, Jia H, Chu Y, Liu T, Chen M, Byers L, Roarty E, Lam VK, Papadimitrakopoulou VA, Wistuba I, Heymach JV, Glisson B, Liao Z, Lee JJ, Futreal PA, Zhang S, Xia X, Zhang J, Wang J. Circulating tumor DNA analysis depicts subclonal architecture and genomic evolution of small cell lung cancer. Nat Commun. 2018 Aug 6;9(1):3114. doi: 10.1038/s41467-018-05327-w. Erratum in: Nat Commun. 2019 Jan 29;10(1):552. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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 | PFS | Progression free of survival | From the first line treatment to the time of disease progression (through study completion, an average of 5 months) |
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