NCT00931190

Brief Summary

The objectives are to evaluate the effectiveness of treatment of cervical intraepithelial neoplasia (CIN) by loop electrosurgical excision procedure using persistence of human papillomavirus (HPV) as outcome, and to perform a long-term follow-up on the ability of HPV testing, as compared to cytology, to predict recurrence of high-grade CIN.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2001

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

First QC Date

June 30, 2009

Last Update Submit

September 14, 2009

Conditions

Human Papillomavirus InfectionCervical Intraepithelial Neoplasia

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

195 women referred for treatment of cervical intraepithelial neoplasia in the cathment area of Umeå university hospital. All women had abnormal smears at enrollment.

You may qualify if:

  • Referral to Umeå university hospital for treatment due to abnormal Pap smear.

You may not qualify if:

  • Lack of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. obstetrics and gynecology, University hospital of Northern Sweden

Umeå, 90185, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cervical smear samples in physiologic saline.

MeSH Terms

Conditions

Papillomavirus InfectionsUterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPrecancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • Anna Söderlund Strand, PhD

    Dept. medical microbiology, Malmö university hospital, Malmö, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2009

First Posted

July 2, 2009

Study Start

February 1, 2001

Study Completion

November 1, 2005

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

SE(1)