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NCT04333212
HPV Genotyping by DR. HPV Genotyping in Vitro Diagnostic Device (IVD) Kit in Exfoliated Cells of the Uterine Cervix
NA trial testing DR. Chip HPV genotyping IVD kit in Cervical Intraepithelial Neoplasia in 1,103 participants. Completed in 8 July 2014.
30 December 2013
Quick facts
| Lead sponsor | Chang Gung Memorial Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 1,103 |
| Start date | 12 December 2012 |
| Primary completion | 30 December 2013 |
| Estimated completion | 8 July 2014 |
| Sites | 4 locations across Taiwan |
Drugs / interventions tested
- DR. Chip HPV genotyping IVD kit
Conditions studied
- Cervical Intraepithelial Neoplasia — all drugs for Cervical Intraepithelial Neoplasia →
- Human Papillomavirus Infection — all drugs for Human Papillomavirus Infection →
- HPV Infection — all drugs for HPV Infection →
Sponsor
Chang Gung Memorial Hospital
Who can join
Adults 21 to 65, female only, with Cervical Intraepithelial Neoplasia or Human Papillomavirus Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
High-risk type human papillomavirus (HPV) is the known etiological agent of cervical cancer. HPV testing and risk stratification by genotyping has been recognized as an effective cervical screening program. A chip for HPV DNA typing based on type-specific polymerase chain reaction (PCR), DR. HPV Genotyping IVD Kit (HPV-27) was developed for genotyping of 27 common HPV types including all high-risk types. We studied its agreement, sensitivity, and specificity compared to DNA sequencing as the gold standard.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04333212
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cervical Intraepithelial Neoplasia
Currently open trials in the same condition.
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- NCT06810427 — A Novel, Low-Cost, Handheld 3D Imaging System for Improved Screening for Cervical Neoplasia in Resource-Limited Settings · NA · active not recruiting
- NCT06191133 — Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma · Phase 1 · recruiting
- NCT06243666 — Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls · active not recruiting
Other Chang Gung Memorial Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04333212 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chang Gung Memorial Hospital
- Last refreshed: 3 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04333212.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing