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Liver CancerNCT01388101

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

A study testing Electrosensing antibody probing system (e- Ab sensor) in people with Liver Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Liver Cancer
What is being tested?
Electrosensing antibody probing system (e- Ab sensor)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTaiwan
Study dates
Sep 2010to Oct 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei, 10051

    Ming-Chih Ho, MD/PhD, 886-2-2312-3456 ext. 65916, mcho1215@ntu.edu.tw

    Ming-Chih Ho, MD/PhD

    Recruiting

Other trials in Taiwan

About this study

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.

Read the 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.

Conditions
Liver Cancer
Being tested
Electrosensing antibody probing system (e- Ab sensor)
Keywords
LECT2
Medical subject headings
Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT01388101
Study groupRoleWhat they receive
LECT2 detectionExperimentalsingle-arm study: Electrosensing antibody probing system(e-AB sensor)
Receives: Device: Electrosensing antibody probing system (e- Ab sensor)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2011 (estimated)
  2. Study startSep 2010
  3. Primary completionOct 2013 (estimated)
  4. Study completionOct 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01388101
Sponsor's protocol ID
201007073R
Status last verified
Dec 2012
First submitted
1 Jul 2011
Last updated
21 Dec 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Electrosensing antibody probing system (e- Ab sensor) in people with Liver Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shiming Lin, PhD (886-2-23123456 ext. 88458, til@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The performance of e- Ab sensor (time frame: 1 Day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2012.

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