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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05066945
Other study ID # 202103748
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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