NCT00728871

Brief Summary

A. To investigate the relationship between serum titer of anti-HPV16 antibody and clinicopathological factors of cervical cancer patients. B. To investigate that if the serum titer of anti-HPV16 antibody could be a prognostic factor in the cervical cancer patients. C. To investigate the serum titer of anti-HPV16 antibody in HPV16-infected populations with various disease status such as infection only, precancerous lesion, and early and advanced cervical cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 6, 2008

Status Verified

August 1, 2008

Enrollment Period

1 month

First QC Date

August 1, 2008

Last Update Submit

August 5, 2008

Conditions

Cervical CancerCervical Intraepithelial Neoplasia

Keywords

cervical cancer, HPV, immunity

Outcome Measures

Primary Outcomes (1)

  • overall survival

    from CS operation to close

Interventions

peripheral blood isolationPROCEDURE

To isolate serum from patient peripheral blood to test the titer of HPV infection and cytokine expression

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cervical intrapeithelial neoplasm
  • Cervical cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Natioanal Taiwan Univ. Hospital

Taipei, Taiwan, 100, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine Cervical DysplasiaPapillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPrecancerous ConditionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chi-An Chen, MD

    National Taiwan University Hospital

    STUDY CHAIR

  • Chi-An Chen, MD

    National Taiwan Univ. Hosp.

    STUDY CHAIR

Central Study Contacts

Chi-An Chen, MD

CONTACT

886-2-2312-3456cachen@ha.mc.ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2008

First Posted

August 6, 2008

Study Start

December 1, 2005

Primary Completion

January 1, 2006

Study Completion

December 1, 2011

Last Updated

August 6, 2008

Record last verified: 2008-08

Locations

CN(1)