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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02198365
Enrollment
250
Registered
2014-07-23
Start date
2007-01-31
Completion date
2009-03-31
Last updated
2014-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Intraepithelial Neoplasia

Keywords

mRNA,, DNA,, integrated HPV DNA, human papillomavirus,, cervical neoplasia

Brief 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.

Interventions

None listed

Sponsors

National Science and Technology Council, Taiwan
CollaboratorOTHER_GOV
Cathay General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* cervical neoplasia * HPV infection patient

Exclusion criteria

* no HPV infection * no intra-epithelial neoplasia lesion

Design outcomes

Primary

MeasureTime frame
level of mRNA expression12 month

Secondary

MeasureTime frame
The integrated HPV DNA12 months

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026