Clinical trial · Observational

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

Application of Circulating Tumor (ctDNA) in the Evaluation of Curative Effect and Prognosis of Small Cell Lung Cancer (SCLC) Patients

NCT05066945CI-TRIAL-00054255not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Small Cell Lung Cancer Extensive Stage	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Observation	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (3)

measure
ctDNA mutation profile at baseline
timeFrame
before treatment ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks)
description
ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance
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)
description
ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance
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)
description
ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

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.

References

Publications (2)

BACKGROUNDMohan 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
BACKGROUNDNong 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. PMID 30082701