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

July 22, 2014 updated by: Chih-Ming Ho, Cathay General Hospital

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

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).

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10630
        • Cathay General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

We will examine 250 baseline liquid-based cytology specimens from women with 100 low-grade squamous intraepithelial lesions (LSILs), 100 high-grade squamous intraepithelial lesions (HSILs), 10 microinvasions and 40 invasive cervical cancers.

Description

Inclusion Criteria:

  • cervical neoplasia

    • HPV infection patient

Exclusion Criteria:

  • no HPV infection

    • no intra-epithelial neoplasia lesion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 2
Group 1: normal pap smear Group 2: cervical neoplasia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
level of mRNA expression
Time Frame: 12 month
12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
The integrated HPV DNA
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cathay General Hospital

Collaborators

National Science Council, Taiwan

Investigators

  • Study Chair: Chih-Ming Ho, Gynecologic Cancer Center, Cathay general Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

January 4, 2009

First Submitted That Met QC Criteria

July 22, 2014

First Posted (ESTIMATE)

July 23, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 23, 2014

Last Update Submitted That Met QC Criteria

July 22, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGOG-128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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