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

Cathay General Hospital

Status: Completed

Conditions: Cervical Intraepithelial Neoplasia

Study type: Observational

Funder types: Other

Identifiers

NCT02198365

TGOG-128

Details and patient eligibility

About

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).

Full 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.

Enrollment: 250 patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• cervical neoplasia

  • HPV infection patient

Exclusion criteria

• no HPV infection

  • no intra-epithelial neoplasia lesion

Trial design

250 participants in 1 patient group

Group 2

Description:

Group 1: normal pap smear Group 2: cervical neoplasia