Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients

NCT ID: NCT02804100

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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Circulating Tumor DNA Lung cancer Plasma DNA

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chunming Ding

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wenfeng Li, Ph.D

Role: STUDY_CHAIR

First Affiliated Hospital of Wenzhou Medical University

Locations

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Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunming Ding, Ph.D

Role: CONTACT

Phone: 86-755-86690871

Email: [email protected]

Ju Luan, Ph.D

Role: CONTACT

Phone: 86-755-86690871

Email: [email protected]

Facility Contacts

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Ju Luan, PhD

Role: primary

Wenfeng Li, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 31691892 (View on PubMed)

Other Identifiers

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4241616009G

Identifier Type: -

Identifier Source: org_study_id