Clinical trial NCT05066945: Application of ctDNA in the Evaluation of Curative Effect and Prognosis of SCLC Patients
Official title: Application of Circulating Tumor (ctDNA) in the Evaluation of Curative Effect and Prognosis of Small Cell Lung Cancer (SCLC) Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Small Cell Lung Cancer Extensive Stage
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: treatment extensive stage small cell lung cancer patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ctDNA mutation profile at baseline
timeFrame: before treatment ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks)
measure: the evolution of ctDNA mutation profile during treatment
timeFrame: After the first cycle of first line treatment upon physicians' request, ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks)
measure: the evolution of ctDNA mutation profile during treatment
timeFrame: After finished the first line treatment, ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks)
Secondary outcomes:
measure: PFS
timeFrame: From the first line treatment to the time of disease progression (through study completion, an average of 5 months)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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.