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Status unknownNCT02804100Updated Nov 1, 2016

Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients

An observational study in Carcinoma, Non-Small-Cell Lung, Bronchial Neoplasms and Carcinoma, Bronchogenic, sponsored by Wenzhou Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-01.

Sponsored by Wenzhou Medical University · Observational

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

A multi-centre observational, non-interventional study is to dynamically monitor the changes of circulating tumor DNA (ctDNA) in late stage NSCLC patients under Gefitinib treatment.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung
  • Bronchial Neoplasms
  • Carcinoma, Bronchogenic
  • Lung Diseases
  • Lung Neoplasms

Keywords

  • Circulating Tumor DNA
  • Lung cancer
  • Plasma DNA
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 200 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Wenzhou Medical University is the lead sponsor of 93 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

NSCLC patients with activating EGFR mutations

Inclusion criteria

  • Provision of informed consent
  • Histologically confirmed stage IIIB/IV NSCLC.
  • Activating EGFR mutations (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q)
  • Able to comply with the required protocol and followed-up procedures, and able to receive oral medications

Exclusion criteria

Exclusion Criteria:

  • Histologically confirmed small cell lung cancer or other metastatic tumors
  • Patient had received prior chemotherapy or EGFR-TKIs treatment
  • Patients who harbor Exon20 T790M mutation
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. dynamic changes of circulating tumor DNA in late stage NSCLC patients under Gefitinib treatment

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Wenzhou Medical University
    Wenzhou, Zhejiang 325000, China
    Recruiting
08

References and documents

Publications

  • Yang Z, Li J, Hu Y, Chen M, Peng D, Zong D, Shang Q, Tao L, Zhao Y, Ni Y, Ye J, Xie Y, Yang L, Lin Q, Cai C, Xu N, Huang X, Dong X, Zhou Z, Yu Y, Shangguan Z, Xu Y, Ying W, Weng M, Yuan Z, Dong Z, Li J, Zheng Z, Pan J, Liu L, Ye J, Zhang Z, Li W, Zhu J, Jin S, Li Y, Ding C. Dynamics of Plasma EGFR T790M Mutation in Advanced NSCLC: A Multicenter Study. Target Oncol. 2019 Dec;14(6):719-728. doi: 10.1007/s11523-019-00682-0. PubMed 31691892 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02804100
Lead sponsor
Wenzhou Medical University
Responsible party
Chunming Ding (Professor, Wenzhou Medical University) — Principal investigator
First posted
Jun 17, 2016
Start date
May 2016
Primary completion
Dec 2017 (estimated)
Completion
Jun 2018 (estimated)
Last update
Nov 1, 2016

Study contacts

Chunming Ding, Ph.D
Contact
cmdingchina@qq.com
86-755-86690871
Ju Luan, Ph.D
Contact
luanluanjuju@163.com
86-755-86690871
Wenfeng Li, Ph.D
study chair · First Affiliated Hospital of Wenzhou Medical University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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