NCT02198365

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
5.4 years until next milestone

First Posted

Study publicly available on registry

July 23, 2014

Completed
Last Updated

July 23, 2014

Status Verified

July 1, 2014

Enrollment Period

2 years

First QC Date

January 4, 2009

Last Update Submit

July 22, 2014

Conditions

Cervical Intraepithelial Neoplasia

Keywords

mRNA,DNA,integrated HPV DNAhuman papillomavirus,cervical neoplasia

Outcome Measures

Primary Outcomes (1)

  • level of mRNA expression

    12 month

Secondary Outcomes (1)

  • The integrated HPV DNA

    12 months

Study Arms (1)

Group 2

Group 1: normal pap smear Group 2: cervical neoplasia

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • cervical neoplasia
  • HPV infection patient

You may not qualify if:

  • no HPV infection
  • no intra-epithelial neoplasia lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cathay General Hospital

Taipei, 10630, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

HPV DNA and mRNA

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Chih-Ming Ho

    Gynecologic Cancer Center, Cathay General Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

January 4, 2009

First Posted

July 23, 2014

Study Start

January 1, 2007

Primary Completion

January 1, 2009

Study Completion

March 1, 2009

Last Updated

July 23, 2014

Record last verified: 2014-07

Locations

TW(1)