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

NCT ID: NCT02198365

Last Updated: 2014-07-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-03-31

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.

Conditions

Cervical Intraepithelial Neoplasia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 2

Group 1: normal pap smear Group 2: cervical neoplasia

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• cervical neoplasia

• HPV infection patient

Exclusion Criteria

• no HPV infection

• no intra-epithelial neoplasia lesion

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Cathay General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chih-Ming Ho

Attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chih-Ming Ho

Role: STUDY_CHAIR

Gynecologic Cancer Center, Cathay General Hospital

Locations

Cathay General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

TGOG-128

Identifier Type: -

Identifier Source: org_study_id