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

NCT05066945 | Not Yet Recruiting

• 1 other identifier: 202103748
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Small Cell Lung Cancer Extensive Stage

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• PFS

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

Interventions

Observation OTHER

observe the association of ctDNA with efficacy of treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

treatment extensive stage small cell lung cancer patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Related 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.

  PMID: 31629061 BACKGROUND

• 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.

  PMID: 30082701 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Deng

CONTACT

13574888840; yogurt1015@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: October 4, 2021
• Study Start: January 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be shared when the clinical trail is completed.