Brief Title
Comparison of Human Papillomavirus Integrated DNA and Messenger RNA in Cervical Neoplasia
Official Title
Comparison of Human Papillomavirus Integrated DNA and Messenger RNA for Detection and Prediction in Progression of 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.
Study Type
Observational
Primary Outcome
level of mRNA expression
Secondary Outcome
The integrated HPV DNA
Condition
Cervical Intraepithelial Neoplasia
Study Arms / Comparison Groups
Group 2
Description: Group 1: normal pap smear Group 2: cervical neoplasia
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
250
Start Date
January 2007
Completion Date
March 2009
Primary Completion Date
January 2009
Eligibility Criteria
Inclusion Criteria:
- cervical neoplasia
- HPV infection patient
Exclusion Criteria:
- no HPV infection
- no intra-epithelial neoplasia lesion
Gender
Female
Ages
20 Years - 80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Chih-Ming Ho, ,
Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT02198365
Organization ID
TGOG-128
Responsible Party
Principal Investigator
Study Sponsor
Cathay General Hospital
Collaborators
National Science Council, Taiwan
Study Sponsor
Chih-Ming Ho, Study Chair, Gynecologic Cancer Center, Cathay General Hospital
Verification Date
July 2014