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Post treatment CIN: Randomised Controlled Trial using hrHPV-testing for prediction of recurrent or residual disease.

Post treatment CIN: Randomised Controlled Trial using hrHPV-testing for prediction of recurrent or residual disease.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26752
Enrollment
204
Registered
2007-02-16
Start date
2002-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post treatment CIN, cytology and hrHPV testing.

Interventions

During follow-up after treatment for high-grade CIN (6, 12 and 24 months) cytology and hrHPV testing will be performed. Colposcopic examinations will be performed in case of abnormal cervical cytology

Sponsors

Department of Obstetrics and Gynaecology, Erasmus University Medical Center Rotterdam, P.O. Box 2040, 3000 CA Rotterdam, the Netherlands. phone:+31-10-4633381 Email: t.helmerhorst@erasmusmc.nl Fax: +31-10-4633315
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women indicated to be treated for high-grade CIN lesions.

Exclusion criteria

Exclusion criteria: 1. Previous treatment for high-grade CIN; 2. An immune compromised state; 3. Previous or current cancer.

Design outcomes

Primary

MeasureTime frame
The primary outcome parameter is the reduction in the number of false-positives achieved by combined testing, through increasing the specificity of testing with unaltered sensitivity, resulting in fewer diagnostic procedures.

Secondary

MeasureTime frame
This will secondarily lead to a decrease in unnecessary examinations and treatment. Possible influence of hrHPV genotyping and effects on health-costs were assessed.

Contacts

Public ContactThJM Helmerhorst

Department of Obstetrics and Gynaecology, Erasmus University Medical Center Rotterdam, P.O. Box 2040

t.helmerhorst@erasmusmc.nl+31-10-4633381

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)