Trial record 20 of 56 for:    Open Studies | "Papillomavirus Infections"

e- Ab Sensor-based Real-time Detection of Oncogenic Human Papilloma Viruses

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01387997
First received: July 1, 2011
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

To develop a real-time diagnostic technique with e- Ab sensor for high risk human papilloma viruses(high risk HPV) detection, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of HPV, the investigators evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction (such as detection of low risk HPV). The potential factors which may interfere with the results would be investigated. With such a real-time diagnostic technique, the investigators hope to obtain information of patients in cost-saving and time-saving way and can give patients early treatment and offer more individualized treatment for our patients.


Condition Intervention
Cervical Cancer
Human Papilloma Virus Infection
Device: Electrosensing antibody probing system (e- Ab sensor)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Nano-mechanical and Nano-electrosensing Devices Based Interaction Force and Interaction Kinetics Analysis of Oncogenic Human Papilloma Viruses

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


Estimated Enrollment: 72
Study Start Date: June 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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 anti-high risk HPV and its antigen (high-risk HPV) present in patients. The system incorporates the use of engineered semiconducive 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 (high-risk HPV) in the test specimens. From assessment of the electric signature of semiconductive anti- high-risk HPV antibodies, the eABprobe could offer sensitive detection and precise quantification of high-risk HPV.

Detailed Description:

Human papillomavirus (HPV)-induced cervical carcinogenesis is proposed to be multi-step in nature. The major steps in cervical carcinogenesis include persistent infection of the metaplastic cervical epithelium with one or more of the oncogenic HPV infection, clonal progression of the infected epithelium to cervical precancer, and further invasion. Although these fundamental steps are well established, several new genetic and immunologic studies have shed light on the factors that influence each of these transitions. Over 150 different HPV subtypes have been identified so far, with a subset of these being classified as high risk for oncogenesis. Persistent infection with oncogenic HPV is the main cause of cervical cancer. Polymerase-chain-reaction (PCR)-based assays show that HPV DNA exist in around 90.7- 96.6% patients with cervical cancer and in 13.4 -15.6% control women. About the detected HPV types in patients, in descending order of frequency, are types 16, 18, 45, 31, 33, 52, 58, and 35. Fifteen HPV types are classified as high-risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 73, and 82); 3 are classified as probable high-risk types (26, 53, and 66); and 12 are classified as low-risk types (6, 11, 40, 42, 43, 44, 54, 61, 70, 72, 81). The most frequently detected high risk HPV types (HPV 16, 51, 52, and 59) are similar in male of different sites, which is compatible with the female incidence.

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 anti-high risk HPV and its antigen (high-risk HPV) present in patients. The system incorporates the use of engineered semiconducive 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 (high-risk HPV) in the test specimens. From assessment of the electric signature of semiconductive anti- high-risk HPV antibodies, the eABprobe could offer sensitive detection and precise quantification of high-risk HPV.

To develop a real-time diagnostic technique with e- Ab sensor for high risk HPV detection, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of HPV, the investigators evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction (such as detection of low risk HPV). The potential factors which may interfere with the results would be investigated. e- Ab sensor threshold decisions must maximize its sensitivity. Therefore, the threshold value in the test group is to find the decision could have 90% sensitivity and 90% specificity.With such a real-time diagnostic technique, the investigators hope to obtain information of patients in cost-saving and time-saving way and can give patients early treatment and offer more individualized treatment for our patients.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A:The patients with confirmed or suspected infection.
  • B: The patients without disease.

Exclusion Criteria:

  • The patients with chronic diseases or medical disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387997

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: Bor-Ching Sheu, MD, PhD    886-2-23123456 ext 71963    bcsheu@ntu.edu.tw   
Principal Investigator: Bor-Ching Sheu, MD,PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Bor-Ching Sheu, MD,PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01387997     History of Changes
Other Study ID Numbers: 201005076R
Study First Received: July 1, 2011
Last Updated: November 19, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
HPV

Additional relevant MeSH terms:
Papillomavirus Infections
Uterine Cervical Neoplasms
Papilloma
Virus Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
DNA Virus Infections
Tumor Virus Infections
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014