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

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198365
• Other study ID #: TGOG-128
• Status: Completed
• Phase: N/A
• First received: January 4, 2009
• Last updated: July 22, 2014
• Start date: January 2007
• Est. completion date: March 2009

Study information

• Verified date: July 2014
• Source: Cathay General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• cervical neoplasia

• HPV infection patient

Exclusion Criteria:

• no HPV infection

• no intra-epithelial neoplasia lesion

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Neoplasms

Locations

Country	Name	City	State
Taiwan	Cathay General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Cathay General Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of mRNA expression		12 month	No
Secondary	The integrated HPV DNA		12 months	No