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e- Ab Sensor-based Real-time Detection of Mutant EGFR in Clinical Specimens From Patients of Non-small Cell Lung Cancer

This study is currently recruiting participants.
Verified March 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01359436
First received: May 23, 2011
Last updated: November 14, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to develop a real-time diagnostic technique with e- Ab sensor for specific EGFR mutation detection in clinical specimens of NSCLC patients, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of EGFR, the investigators evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction (such as detection of EGFR mutations other than L858R and DelL746-A750). The potential factors which may interfere with the results would be investigated. With such technique, the investigators can obtain EGFR mutation information of NSCLC patients in cost-saving and time-saving way and can offer more individualized treatment for the investigators patients.


Condition Intervention
Non-small Cell Lung Cancer (NSCLC)
 Device: Electrosensing antibody probing system (e- Ab sensing)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: e- Ab Sensor-based Real-time Detection of Mutant EGFR in Clinical Specimens From Patients of Non-small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The performance of e- Ab sensor [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    In comparison with results from direct sequencing of EGFR, we evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction (such as detection of EGFR mutations other than L858R and DelL746-A750)


Estimated Enrollment: 200
Study Start Date: July 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electrosensing antibody probing system (e- Ab sensing) Device: Electrosensing antibody probing system (e- Ab sensing)
Electrosensing antibody probing system (e- Ab sensing), which was developed for the rapid and sensitive detection of hapten, proteins or viral antigen in medical samples, will be used for analyzing the interaction kinetics between mutation-specific anti-EGFR and its antigen mutant EGFR present in NSCLC. The system incorporates the use of engineered semiconductive antibodies or virus in vertical and lateral chip (eAbchip) or lateral flow through (eAbsignal) formats. In electrosensing antibody probing, semiconductive antibodies are bound as a suitable electrosensing probe which specifically and selectively binds mutant EGFR polypeptide target molecules in the test specimen.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion: Patients will be enrolled if they fulfill all of the following criteria

  1. With indication for the following interventions:

    Thoracentesis Fine-needle aspiration and biopsy of primary tumor or metastases Bronchoalveolar lavage

  2. With enough residual specimens for further study (Patients would be excluded if they have only limited amount of clinical specimens, which should all be sent for clinical analysis.)
  3. Consent is obtained from the patient

Exclusion Criteria:

  • Patients will be excluded if they couldn't sign the consent. Otherwise, no specific exclusion criteria were considered.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359436

Contacts
Contact: Kuei-Pin Chung, MD 886-2-2356-2905 gbchung@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Pan-Chyr Yang, PhD     886-2-2356-2905     pcyang@ntu.edu.tw    
Principal Investigator: Pan-Chyr Yang, PhD            
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Pan-Chyr Yang, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01359436     History of Changes
Other Study ID Numbers: 201007059R
Study First Received: May 23, 2011
Last Updated: November 14, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013