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

Overview

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

• Other Observation
  observe the association of ctDNA with efficacy of treatment

Primary outcome measures

• ctDNA mutation profile at baseline [Time frame: before treatment ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks)]
• the evolution of ctDNA mutation profile during treatment [Time frame: 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 [Time frame: After finished the first line treatment, ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks)]

Secondary outcome measures (1)

• PFS [Time frame: From the first line treatment to the time of disease progression (through study completion, an average of 5 months)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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. PMID 31629061
• 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/s PMID 30082701

Identifiers

NCT: NCT05066945 · 202103748

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗