NCT02666755

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

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

January 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

January 19, 2016

Last Update Submit

January 28, 2016

Conditions

Lung Neoplasms

Keywords

Lung Neoplasms digital polymerase chain reaction

Outcome Measures

Primary Outcomes (1)

  • sensitivity

    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.

    2 years

Secondary Outcomes (1)

  • specificity

    2 years

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients diagnosed with NSCLC

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Zhu G, Ye X, Dong Z, Lu YC, Sun Y, Liu Y, McCormack R, Gu Y, Liu X. Highly Sensitive Droplet Digital PCR Method for Detection of EGFR-Activating Mutations in Plasma Cell-Free DNA from Patients with Advanced Non-Small Cell Lung Cancer. J Mol Diagn. 2015 May;17(3):265-72. doi: 10.1016/j.jmoldx.2015.01.004. Epub 2015 Mar 11.

    PMID: 25769900BACKGROUND

  • Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.

    PMID: 21296855BACKGROUND

  • Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009 Sep 3;361(10):947-57. doi: 10.1056/NEJMoa0810699. Epub 2009 Aug 19.

    PMID: 19692680BACKGROUND

  • Zhou C, Wu YL, Chen G, Feng J, Liu XQ, Wang C, Zhang S, Wang J, Zhou S, Ren S, Lu S, Zhang L, Hu C, Hu C, Luo Y, Chen L, Ye M, Huang J, Zhi X, Zhang Y, Xiu Q, Ma J, Zhang L, You C. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2011 Aug;12(8):735-42. doi: 10.1016/S1470-2045(11)70184-X. Epub 2011 Jul 23.

    PMID: 21783417BACKGROUND

  • Yu M, Bardia A, Wittner BS, Stott SL, Smas ME, Ting DT, Isakoff SJ, Ciciliano JC, Wells MN, Shah AM, Concannon KF, Donaldson MC, Sequist LV, Brachtel E, Sgroi D, Baselga J, Ramaswamy S, Toner M, Haber DA, Maheswaran S. Circulating breast tumor cells exhibit dynamic changes in epithelial and mesenchymal composition. Science. 2013 Feb 1;339(6119):580-4. doi: 10.1126/science.1228522.

    PMID: 23372014RESULT

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

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jian Zhang, Doctor

    Xijing Hospital

    STUDY DIRECTOR

Central Study Contacts

Ning Chang, Postgraduate

CONTACT

15229491635changninggirl@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
director of Respiration Department

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 28, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

April 1, 2018

Last Updated

January 29, 2016

Record last verified: 2016-01