Skip to main content
Clinical Trials/NCT01388101
NCT01388101
Unknown
Not Applicable

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

National Taiwan University Hospital1 site in 1 country80 target enrollmentSeptember 2010
ConditionsLiver Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Liver Cancer
Sponsor
National Taiwan University Hospital
Enrollment
80
Locations
1
Primary Endpoint
The performance of e- Ab sensor
Last Updated
13 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
October 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Inmates, aboriginal peoples, pregnant women, mental patients, students, subordinates and other vulnerable groups.
  • Patients with malignant tumors.
  • Patients will be excluded if they couldn't sign the consent.

Outcomes

Primary Outcomes

The performance of e- Ab sensor

Time Frame: 1 Day

In comparison with results from direct concentration of LECT2, we evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction.

Study Sites (1)

Loading locations...

Similar Trials