- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01387997
e- Ab Sensor-based Real-time Detection of Oncogenic Human Papilloma Viruses
Nano-mechanical and Nano-electrosensing Devices Based Interaction Force and Interaction Kinetics Analysis of Oncogenic Human Papilloma Viruses
연구 개요
상태
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
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Taipei, 대만, 10051
- 모병
- National Taiwan University Hospital
-
연락하다:
- Bor-Ching Sheu, MD, PhD
- 전화번호: 71963 886-2-23123456
- 이메일: bcsheu@ntu.edu.tw
-
수석 연구원:
- Bor-Ching Sheu, MD,PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 1
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The performance of e- Ab sensor
기간: 1 Day
|
In comparison with results from direct sequencing of HPV, we evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction.
|
1 Day
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Bor-Ching Sheu, MD,PhD, National Taiwan University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 201005076R
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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