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NCT00931190 Clinical Trial

Use of Human Papillomavirus Persistence for Determination of Treatment Efficacy Among Women With Cervical Dysplasia

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:
Evaluation of the Use of Human Papillomavirus Persistence for Determination of the Treatment Efficacy Among Women With Cervical Intraepithelial Neoplasia, and for Prediction of Recurrence of Cervical Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00931190
Other study ID # 95-240
Secondary ID
Status Completed
Phase N/A
First received June 30, 2009
Last updated September 14, 2009
Start date February 2001
Est. completion date November 2005

Study information
Verified date September 2009
Source Lund University
Contact n/a
Is FDA regulated No
Health authority Sweden: Institutional Review Board
Study type Observational

Clinical Trial 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.

Description:

Cervical samples for human papillomavirus (HPV) DNA analysis and cytological analysis were obtained from women with abnormal smears referred to Umeå university hospital, Sweden, for treatment with conization. These women were scheduled for HPV DNA testing and Pap smears before and 3, 6, 12, 24 and 36 months after treatment. The HPV DNA testing was performed with a PCR-based genotyping method.

Recruitment information / eligibility
Status Completed
Enrollment 195
Est. completion date November 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Lack of informed consent.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Dept. obstetrics and gynecology, University hospital of Northern Sweden Umeå

Sponsors (2)
Lead Sponsor Collaborator
Lund University Swedish Cancer Society

Country where clinical trial is conducted

Sweden, 

See also
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Completed NCT02907333 - Testing Use of Condoms on Regression of Cervical Intraepithelial Neoplasia N/A
Recruiting NCT02576262 - HPV Integration Testing for Human Papillomavirus-Positive Women N/A
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Active, not recruiting NCT03429582 - Comparison of Cervical CIN II/III Treatment Outcomes With Thermal Ablation Device N/A
Active, not recruiting NCT02140021 - Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer N/A
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Withdrawn NCT03143491 - Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN) Phase 2
Completed NCT03293628 - Comparing Two Techniques of Haemostasis After Cervical Conization Phase 2
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Completed NCT02481414 - A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions Phase 2
Completed NCT02247999 - Improving Cervical Cancer Screening Among HIV-Infected Women in India
Recruiting NCT04646954 - DNA Methylation Testing for the Screening of Uterine Cervical Lesion Phase 3
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