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Novel Detection System for Lung Cancer Curative Effect Monitoring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02666755
Recruitment Status : Unknown
Verified January 2016 by Jian Zhang, Air Force Military Medical University, China.
Recruitment status was:  Not yet recruiting
First Posted : January 28, 2016
Last Update Posted : January 29, 2016
Information provided by (Responsible Party):
Jian Zhang, Air Force Military Medical University, China

Brief Summary:
The purpose of this study is to investigate the sensitivity,specificity and concordance rate of EGFR testing results in plasma in comparison of results in matched tumor tissues tested by amplification refractory mutation system(ARMS). Moreover, the investigators correlate our findings in plasma with survival of advanced patients.

Condition or disease
Lung Neoplasms

Detailed Description:
Non-small cell lung cancer (NSCLC), accounting for 80% of all lung cancers, is a leading cause of cancer deaths worldwide. Inhibition of epidermal growth factor receptor (EGFR) kinase activity by EGFR tyrosine kinase inhibitors, such as gefitinib and erlotinib, can result in improved response and prolonged progression-free survival (PFS) in selected non-small cell lung cancer (NSCLC) patients harboring sensitizing EGFR mutations, especially the exon 19del and exon 21(L858R) mutations. Unfortunately, about 50%-60% patients who accept EGFR tyrosine kinase inhibitors with sensitizing mutations will receive resistance mutations, the T790M resistance is a target of active pharmaceutical development. So EGFR mutation testing is a step in identifying the right patients for EGFR tyrosine kinase inhibitors treatment. Now tissue samples and tumor cytologic samples are accepted as appropriate sample types for EGFR mutation detection, but these samples are not always available on or after diagnosis, and, even when available, they may be of insufficient quality or quantity for mutation testing. Noninvasive techniques for tumor genotyping may be needed to fully realize, such as plasma sample. Cell-free DNA (cf-DNA) in plasma is a kind of fresh and realtime sample, and has been shown to be promising for the detection of sensitizing EGFR mutations even the resistance mutation(T790M). However, a challenge was also raised about how to detect the low abundance of mutant alleles in plasma. In our study Droplet Digital polymerase chain reaction and Realtime polymerase chain reaction will be used to assess the EGFR mutation in plasma DNA samples from patients with advanced NSCLC before and after EGFR tyrosine kinase inhibitors therapy.

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Novel Detection System for Detecting Epidermal Growth Factor Receptor Mutation in Plasma in Non-small Cell Lung Cancer
Study Start Date : January 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. sensitivity [ Time Frame: 2 years ]
    comparing with results in tissues, tne investigators can get the sensitivity of results in plasma for Epidermal Growth Factor Receptor mutation in Non-small cell lung cancer.

Secondary Outcome Measures :
  1. specificity [ Time Frame: 2 years ]
    comparing with results in tissues, the investigators can get the specificity of results in plasma for Epidermal Growth Factor Receptor mutation in Non-small cell lung cancer.

Biospecimen Retention:   Samples With DNA
Each specimen was collected into one 10mL EDTA-containing vacutainer and was spun into plasma within 4 hours of collection. cfDNA was extracted from 2 mL of plasma, and the final DNA eluent was frozen at- 20℃ until genotyping

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients diagnosed with NSCLC

Inclusion Criteria:

  1. Aged 18-85 years old;
  2. The diagnosis of lung cancer by pathological examination;
  3. At least one specific measurable lung cancer lesions (according to RECIST criteria, application of spiral CT, the lesion diameter 10 mm or higher);
  4. People understand and are willing to accept the study, and sign the informed consent

Exclusion Criteria:

  1. With severe hemorrhagic disease;
  2. Compliance is poor, can't cooperate with the visitor.

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 identifier (NCT number): NCT02666755

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Contact: Ning Chang, Postgraduate 15229491635

Sponsors and Collaborators
Jian Zhang
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Study Director: Jian Zhang, Doctor Xijing Hospital
Publications of Results:
Other Publications:
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Responsible Party: Jian Zhang, director of Respiration Department, Air Force Military Medical University, China Identifier: NCT02666755    
Other Study ID Numbers: 15229491635
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jian Zhang, Air Force Military Medical University, China:
Lung Neoplasms digital polymerase chain reaction
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases