NCT02804100

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

1.6 years

First QC Date

June 14, 2016

Last Update Submit

October 31, 2016

Conditions

Carcinoma, Non-Small-Cell LungBronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesLung Neoplasms

Keywords

Circulating Tumor DNALung cancerPlasma DNA

Outcome Measures

Primary Outcomes (1)

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

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

NSCLC patients with activating EGFR mutations

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31691892DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungBronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesLung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsRespiratory Tract DiseasesBronchial Diseases

Study Officials

  • Wenfeng Li, Ph.D

    First Affiliated Hospital of Wenzhou Medical University

    STUDY CHAIR

Central Study Contacts

Chunming Ding, Ph.D

CONTACT

86-755-86690871cmdingchina@qq.com

Ju Luan, Ph.D

CONTACT

86-755-86690871luanluanjuju@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 17, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

CN(1)