NCT02198365

Comparison of Human Papillomavirus Integrated DNA and Messenger RNA in Cervical Neoplasia

Comparison of Human Papillomavirus Integrated DNA and Messenger RNA for Detection and Prediction in Progression of Cervical Neoplasia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: Cathay General Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The investigators hypothesis is HPV integration could result in expression of oncogene transcripts, and not only constitutive expression but also the level of expression will be decisive for transformation and the maintenance of the malignant phenotype. Moreover, the expression and level of HPV viral transcripts not HPV DNA viral loads is correlated to the severity in cervical intraepithelial neoplasia (CIN) and cervical carcinomas (CxCa).

Detailed description

In the investigators proposal, the investigators will examine at least 250 baseline liquid-based cytology specimens from women with normal cytology, low-grade squamous intraepithelial lesions (LSILs), high-grade squamous intraepithelial lesions (HSILs), microinvasions and invasive cervical cancers. Specimens will be tested for HPV DNA using HPV blot and type-specific PCR including type 16, 18, 52, 58, 31, 33, 39, 45, 51, 56, 59, 68, 6, and 11. Cervical specimens from women with HPV DNA types 16, 18, 52, 58, 31 and 33, which are the most prevalent oncogenic types in Taiwan, will be examined for physical status of viral DNA tested by real-time PCR and FISH, along with level of expression in mRNA.

Conditions

• Cervical Intraepithelial Neoplasia

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-01-01
• Completion: 2009-03-01
• First posted: 2014-07-23
• Last updated: 2014-07-23

Locations

1 site across 1 country: Taiwan