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

NCT01388101 | Unknown

• 1 other identifier: 201007073R
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer

Keywords

LECT2

Outcome Measures

Primary Outcomes (1)

• 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.

  1 Day

Study Arms (1)

LECT2 detection

EXPERIMENTAL

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

Device: Electrosensing antibody probing system (e- Ab sensor)

Interventions

Electrosensing antibody probing system (e- Ab sensor) DEVICE

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.

LECT2 detection

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10051, Taiwan

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Ming-Chih Ho, MD,PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiming Lin, PhD

CONTACT

886-2-23123456; til@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 6, 2011
• Study Start: September 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 21, 2012

Record last verified: 2012-12

Locations

TW (1)