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


- candidate number2472
- NTR NumberNTR908
- ISRCTNISRCTN31244687
- Date ISRCTN created6-mrt-2007
- date ISRCTN requested6-mrt-2007
- Date Registered NTR16-feb-2007
- Secondary IDsN/A 
- Public TitlePost treatment CIN: Randomised Controlled Trial using hrHPV-testing for prediction of recurrent or residual disease.
- Scientific TitlePost treatment CIN: Randomised Controlled Trial using hrHPV-testing for prediction of recurrent or residual disease.
- ACRONYMN/A
- hypothesisAccording to the current national guidelines, as formulated by the Dutch Society of Cervical Pathology and Colposcopy in 1995, the follow-up in women treated for high grade Cervical Intraepithelial Neoplasia lesions consists of cervical cytological monitoring at 6, 12 and 24 months. Colposcopic examination will be performed in case of abnormal cervical cytology. One of the drawbacks of cervical cytological follow-up after treatment is a high number of false-positive findings. Approximately 20% of the women present an abnormal cervical cytology. However in only half of them an underlying residual or recurrent CIN will be found, resulting in unnecessary diagnostic procedures to determine the actual residual or recurrent CIN disease From several studies we know that a persistent infection with high risk Human Papilloma Virus (HPV) is necessary for the development, maintenance and progression of primary CIN lesions. It is assumed that effective treatment for CIN lesions results in the eradication of the high-risk HPV infection present before treatment. However in residual or recurrent CIN disease is high risk HPV still present. The use of the high risk HPV-test during follow-up, as an adjunct to cytological follow-up, will lead to a better selection of those women at risk for residual or recurrent CIN after initial treatment for high grade CIN lesions. This selection results in diagnostic procedures only in patients with actual risk for developing recurrent or residual CIN lesions. Unnecessary diagnostic procedures in patients without residual or recurrent CIN can be prevented. Consequently, this policy leads to can lead to important reduction in health costs. Moreover, a better quality-of-life for the woman can be obtained.
- Healt Condition(s) or Problem(s) studiedPost treatment , Cytology , High risc Human Papilloma Virus (HPV) testing, Intraepithelial neoplasia, Cervix
- Inclusion criteriaWomen indicated to be treated for high-grade CIN lesions.
- Exclusion criteria1. Previous treatment for high-grade CIN;
2. An immune compromised state;
3. Previous or current cancer.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2002
- planned closingdate1-sep-2004
- Target number of participants204
- InterventionsDuring 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 (current policy group A) or both abnormal cervical cytology and a positive HPV test (group B). At the end of follow-up all participants, irrespective of the test results, will undergo colposcopic examination for end-histology to exclude residual or recurrent CIN lesions and to establish specificity and sensitivity of both follow-up policies.
- Primary outcomeThe 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 outcomeThis will secondarily lead to a decrease in unnecessary examinations and treatment. Possible influence of hrHPV genotyping and effects on health-costs were assessed.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf.dr. ThJM Helmerhorst
- CONTACT for SCIENTIFIC QUERIESProf.dr. ThJM Helmerhorst
- Sponsor/Initiator Erasmus Medical Center, Department of Obstetrics and Gynecology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryFollow-up after treatment for high-grade CIN (Cervical Intraepithelial Neoplasia 2/3) consists of cervical cytological monitoring at 6, 12 and 24 months, to determine residual or recurrent CIN lesions (CIN 2/3). Colposcopic examination will be performed in case of abnormal cervical cytology. One of the drawbacks of cervical cytological follow-up after treatment is a high number of false-positive findings. Approximately 20% of the women present an abnormal cervical cytology. However in more than half of them no underlying residual or recurrent CIN will be found, resulting in unnecessary diagnostic procedures. A persistent infection with high risk Human Papilloma Virus (hrHPV) is necessary for the development, maintenance and progression of primary CIN lesions. It is assumed that effective treatment for CIN lesions results in the eradication of the hrHPV infection present before treatment, while in residual or recurrent CIN disease the hrHPV infection is still present. The use of combined testing by hrHPV and cytology can lead to a better selection of women at risk for residual or recurrent CIN after initial treatment for high-grade CIN lesions. This selection results in diagnostic procedures being performed only in patients Consequently, this policy can lead to an important reduction in health costs and anxiety.
In our proposal we describe a randomised clinical trial, in which HPV-testing as an adjunct to cervical cytology will be performed during follow-up after treatment for high grade CIN lesions. After inclusion patients will be randomised in two groups. Colposcopic examination will be performed in group A in case of abnormal cervical cytology and in group B in case of both abnormal cytology and a positive high risk HPV-test. At the end of the study all women, irrespective of the test results, undergo colposcopic examination for end-histology to exclude residual or recurrent CIN and to establish specificity and sensitivity of both follow-up policies.
- Main changes (audit trail)
- RECORD16-feb-2007 - 16-jun-2008


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