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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Small Cell Lung Cancer Extensive Stage
• Intervention / Treatment: Other: Observation

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Deng; Phone Number: 13574888840; Email: yogurt1015@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

treatment extensive stage small cell lung cancer patients

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: 202103748

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all IPD data for publication
• IPD Sharing Time Frame: IPD will be shared when the clinical trail is completed.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No