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Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients

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ClinicalTrials.gov Identifier: NCT02804100
Recruitment Status : Unknown
Verified October 2016 by Chunming Ding, Wenzhou Medical University.
Recruitment status was:  Recruiting
First Posted : June 17, 2016
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Chunming Ding, Wenzhou Medical University

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.

Condition or disease
Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi-centre Observational Study on Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients Under Gefitinib Treatment
Study Start Date : May 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. dynamic changes of circulating tumor DNA in late stage NSCLC patients under Gefitinib treatment [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
NSCLC patients with activating EGFR mutations
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804100


Contacts
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Contact: Chunming Ding, Ph.D 86-755-86690871 cmdingchina@qq.com
Contact: Ju Luan, Ph.D 86-755-86690871 luanluanjuju@163.com

Locations
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China, Zhejiang
Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Ju Luan, PhD       luanluanjuju@163.com   
Contact: Wenfeng Li, MD         
Sponsors and Collaborators
Wenzhou Medical University
Investigators
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Study Chair: Wenfeng Li, Ph.D First Affiliated Hospital of Wenzhou Medical University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chunming Ding, Professor, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT02804100    
Other Study ID Numbers: 4241616009G
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Chunming Ding, Wenzhou Medical University:
Circulating Tumor DNA
Lung cancer
Plasma DNA
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Bronchial Diseases