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

Primary Purpose

Liver Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Electrosensing antibody probing system (e- Ab sensor)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Cancer focused on measuring LECT2

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LECT2 detection

Arm Description

single-arm study: Electrosensing antibody probing system(e-AB sensor)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 1, 2011
Last Updated
December 20, 2012
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01388101
Brief Title
Real-time Diagnosis of Serum LECT 2 in Patient With Liver Cancer Using Electronic Antibody Sensor (e- Ab Sensor)
Official Title
Real-time Diagnosis of Serum LECT 2 in Patient With Liver Cancer Using Electronic Antibody Sensor (e- Ab Sensor)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
LECT2

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LECT2 detection
Arm Type
Experimental
Arm Description
single-arm study: Electrosensing antibody probing system(e-AB sensor)
Intervention Type
Device
Intervention Name(s)
Electrosensing antibody probing system (e- Ab sensor)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The performance of e- Ab sensor
Description
In comparison with results from direct concentration of LECT2, we evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction.
Time Frame
1 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiming Lin, PhD
Phone
886-2-23123456
Ext
88458
Email
til@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Chih Ho, MD,PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10051
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-Chih Ho, MD/PhD
Phone
886-2-2312-3456
Ext
65916
Email
mcho1215@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Ming-Chih Ho, MD/PhD

12. IPD Sharing Statement

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

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