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

Not yet recruiting

• Conditions: Small Cell Lung Cancer Extensive Stage

• Registration Number: NCT05066945
• Lead Sponsor: Xiangya Hospital of Central South University

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.

Study Timeline

• Study First Submitted: 2021-08-19
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-22
• Last Update Submitted: 2021-09-22
• Study First Posted: 2021-10-04
• Last Update Posted: 2021-10-04
• Study Start: 2022-01-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ctDNA mutation profile at baseline	before treatment ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks)	ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance
the evolution of ctDNA mutation profile during treatment	After finished the first line treatment, ctDNA mutation analysis and clonal analysis (each cycle is 3 weeks)	ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance

Secondary Outcome Measures

Name	Time	Method
PFS	From the first line treatment to the time of disease progression (through study completion, an average of 5 months)	Progression free of survival