- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01388049
e- Ab Sensor - Based Real-time Diagnosis of Enterovirus Type 71
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Entervirus 71 is one of the most important infectious diseases in children and the important concern in public health. Since 1998, EV71 has become an endemic disease in Taiwan and caused hundreds of severe cases and dozens of fatal cases each year due to lack of EV71 vaccine. Family transmission study also showed that it is highly contagious among households as well as in daycares or kindergartens. Therefore, a rapid diagnosis is clinically necessary and can provide clinicians the rapid answers and make early treatment possible to reduce the complications and case-fatality rate. In addition, early diagnosis of the patients will alert parents and public health workers to prevent the contacts earlier and to limit the EV71 spread.
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 Q.anti-EV71 and its antigen EV71 present in EV71 patients and normal sample. The system incorporates the use of engineered semiconductive antibodies or virus in vertical and lateral chip (eVchip) or lateral flow through (eVsignal) formats. In electrosensing virus probing, semiconductive antibodies are bound as a suitable electrosensing probe which specifically and selectively binds EV71 epitope target molecules in the test serum. In comparison with results from direct sequencing of EV71, the investigators evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction. 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 technique, the investigators hope to make early diagnosis and give EV71 patients early treatment to reduce the complications and case-fatality rate.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Taipei, Taiwan, 10051
- Reclutamento
- National Taiwan University Hospital
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Contatto:
- Luan-Yin Chang, MD,PhD
- Numero di telefono: 71528 886-2-2312-3456
- Email: lychang@ntu.edu.tw
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Investigatore principale:
- Luan-Yin Chang, MD/PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- A: The patients with confirmed or suspected infection.
- B: The patients without disease.
Exclusion Criteria:
- Patients will be excluded if they couldn't sign the consent.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: virus detection
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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-EV71 antibody and its antigen (EV71) 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 (EV71) in the test specimens.
From assessment of the electric signature of semiconductive anti-EV71 antibodies, the eABprobe could offer sensitive detection and precise quantification of EV71.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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The performance of e- Ab sensor
Lasso di tempo: 1 Day
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In comparison with results from direct sequencing of EV71, we evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction.
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1 Day
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Luan-Yin Chang, MD,PhD, National Taiwan University Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 201007053R
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su EV71
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Sinovac Biotech Co., LtdCompletato
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Jiangsu Province Centers for Disease Control and...Bejing Vigoo Biological Co., LTDCompletatoMalattia associata a EV71Cina
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Cancer Institute and Hospital, Chinese Academy...Beijing Chaoyang District Centre for Disease Control and Prevention; Neimenggu...SconosciutoSicurezza del vaccino EV71 inattivato | Immunizzazione del vaccino EV71 inattivatoCina
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Jiangsu Province Centers for Disease Control and...Bejing Vigoo Biological Co., LTDCompletatoBiologia dei sistemi | Gene precoce | Vaccino EV71Cina
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Institute of Medical Biology, Chinese Academy of...Guangxi Center for Disease Control and PreventionCompletatoL'efficacia del vaccino EV71 inattivato (KMB17) contro l'HFMD nei bambini e nei neonati cinesiCina
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Jiangsu Province Centers for Disease Control and...CompletatoMalattia della mano, dell'afta epizootica | Anti-EV71 | Anti-CVA16Cina
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Jiangsu Province Centers for Disease Control and...Bejing Vigoo Biological Co., LTDCompletatoMalattia della mano, dell'afta epizootica | Erpangina | Altre malattie associate a EV71Cina
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Institute of Medical Biology, Chinese Academy of...Guangxi Center for Disease Control and PreventionCompletatoLo studio si è concentrato sulla sicurezza del vaccino EV71 inattivato (cellula diploide umana) contro l'afta epizootica nei bambini e nei neonati cinesiCina