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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02198365
Other study ID # TGOG-128
Secondary ID
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


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
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