Real-time Diagnosis of Serum LECT 2 in Patient With Liver Cancer Using Electronic Antibody Sensor (e- Ab Sensor)

This study is currently recruiting participants.
Verified December 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01388101
First received: July 1, 2011
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

To develop a real-time diagnostic technique with e- Ab sensor for specific LECT2 detection in clinical specimens of Hepatocellular carcinoma (HCC) patients, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of LECT2, the investigators evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction. With such technique, the investigators can obtain LECT2 information of HCC patients in cost-saving and time-saving way and can offer more individualized treatment for our patients.


Condition Intervention
Liver Cancer
Device: Electrosensing antibody probing system (e- Ab sensor)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Real-time Diagnosis of Serum LECT 2 in Patient With Liver Cancer Using Electronic Antibody Sensor (e- Ab Sensor)

Resource links provided by NLM:


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 concentration of LECT2, we evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction.


Estimated Enrollment: 80
Study Start Date: September 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LECT2 detection
single-arm study: Electrosensing antibody probing system(e-AB sensor)
Device: Electrosensing antibody probing system (e- Ab sensor)
Electrosensing antibody probing system (e- Ab sensor), 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 specific anti- LECT2 and its antigen (LECT2 with liver cancer) present in the specimens of patients with liver cancer. 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 targeted molecules (i.e. specific LECT2) in the test specimens.

Detailed Description:

Hepatocellular carcinoma (HCC) is one of the most common types of cancer in the world. High cancer recurrence is still the major cause of death of HCC patients. The major poor prognostic factors included vascular invasion, high α-FP, large tumor size, or tumor satellitosis, etc. Among the various literature reports with multivariate analysis, vascular invasion of the tumor is the major contribution of high recurrence and poor survival. Therefore, identifying differentially expressed genes between vascular-invasion and non-vascular invasion of HCCs is important.

After suppression subtractive hybridization and microarray experiments, the investigators identified 20 differentially-expressed genes between vascular-invasive, and non-vascular invasive HCCs. One of the most interesting gene is leukocyte cell-derived chemotaxin 2 (LECT2). Further evaluation of the role of LECT2 on HCCs, the investigators found (1) Higher invasiveness, the lower of LECT2 gene expression in the HCC cell lines. (2) Conditioned medium with high LECT2 content will inhibit HCC invasion. (3) The invasion ability decreased in LECT2-overexpression hepatoma cell line. (4) In transendothelial cell migration assay, the investigators could observed invasion ability increased when LECT2 was knockdown in HCC cell line. (5) The lower expression of LECT2 gene in human HCCs correlate with higher tumor stage, early recurrence, and poor prognosis. (6) In vivo experiments revealed LECT2 can inhibit the ability of intravasation or metastatic ability of HCC.

Electrosensing antibody probing system (e- Ab sensor), 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 specific anti- LECT2 and its antigen (LECT2 with liver cancer) present in the specimens of patients with liver cancer. 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 targeted molecules (i.e. specific LECT2) in the test specimens. From assessment of the electric signature of semiconductive mutation-specific anti-LECT2 antibodies, the eABprobe could offer sensitive detection and precise quantification of specific LECT2.

To develop a real-time diagnostic technique with e- Ab sensor for specific LECT2 detection in clinical specimens of HCC patients, the investigators conduct a prospective clinical study. The investigators evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction. With such technique, the investigators can obtain LECT2 information of HCC patients in cost-saving and time-saving way and can offer more individualized treatment for our patients.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patients with liver cancer.
  • The patients without liver cancer.

Exclusion Criteria:

  1. Inmates, aboriginal peoples, pregnant women, mental patients, students, subordinates and other vulnerable groups.
  2. Patients with malignant tumors.
  3. Patients will be excluded if they couldn't sign the consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388101

Contacts
Contact: Shiming Lin, PhD 886-2-23123456 ext 88458 til@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10051
Contact: Ming-Chih Ho, MD/PhD    886-2-2312-3456 ext 65916    mcho1215@ntu.edu.tw   
Principal Investigator: Ming-Chih Ho, MD/PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ming-Chih Ho, MD,PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01388101     History of Changes
Other Study ID Numbers: 201007073R
Study First Received: July 1, 2011
Last Updated: December 20, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
LECT2

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014