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

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.

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Key information

Conditions

Small Cell Lung Cancer Extensive Stage

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observation

Other

observe the association of ctDNA with efficacy of treatment

Primary outcomes

ctDNA mutation profile at baseline

Time frame: 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

Time frame: After the first cycle of first line treatment upon physicians' request, 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

Time frame: 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 outcomes

PFS

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

Progression free of survival

Study contacts

Contact information is provided by the study sponsor or research team.

Deng

CONTACT

[email protected]

13574888840

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2026
First posted: Oct 4, 2021
Registry last updated: Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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