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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05066945
• Other study ID #: 202103748
• Status: Not yet recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2021
• Source: Xiangya Hospital of Central South University
• Contact: Deng
• Phone: 13574888840
• Email: yogurt1015[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer Extensive Stage
• Small Cell Lung Carcinoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

References & Publications (2)

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

Outcome

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)