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ISRCTN
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ISRCTN31244687
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ClinicalTrials.gov identifier
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Public title
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Post treatment cervical intraepithelial neoplasia: randomised controlled trial using high-risk human papilloma virus testing for prediction of recurrent or residual disease
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Scientific title
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Acronym
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N/A
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Serial number at source
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NTR908
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Study hypothesis
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According 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 (CIN) 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 papillomavirus (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.
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Ethics approval
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Approval received from the Medical Ethical Research Commission Erasmus University Medical Centre Rotterdam (Medische Ethishe Toetsings Commissie Erasmus MC) on the 6th February 2002 (ref: MEC 197.749/2000/266).
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Study design
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Randomised, non-controlled, parallel group, multicentre clinical trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Post treatment CIN, cytology, high-risk HPV testing
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Participants - inclusion criteria
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Women indicated to be treated for high-grade CIN lesions.
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Participants - exclusion criteria
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1. Previous treatment for high-grade CIN
2. An immune compromised state
3. Previous or current cancer
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Anticipated start date
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01/07/2002
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Anticipated end date
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01/09/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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204
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Interventions
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During follow-up after treatment for high-grade CIN (6, 12 and 24 months) cytology and high-risk HPV 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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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1. A decrease in unnecessary examinations and treatment
2. Possible influence of high-risk HPV genotyping and effects on health-costs
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Sources of funding
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Erasmus Medical Centre (The Netherlands)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19048594
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Contact name
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Prof
T H J M
Helmerhorst
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Address
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Erasmus University Medical Centre Rotterdam
Department of Obstetrics and Gynaecology
P.O. Box 2040
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City/town
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Rotterdam
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Zip/Postcode
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3000 CA
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Country
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Netherlands
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Tel
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+31 (0)10 463 3381
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Fax
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+31 (0)10 463 3315
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Email
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t.helmerhorst@erasmusmc.nl
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Sponsor
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Erasmus Medical Centre (The Netherlands)
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Address
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Department of Obstetrics and Gynaecology
P.O. Box 2040
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City/town
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Rotterdam
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Zip/Postcode
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3015 GJ
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Country
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Netherlands
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Sponsor website:
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http://www.erasmusmc.nl/
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Date applied
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06/03/2007
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Last edited
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24/12/2008
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Date ISRCTN assigned
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06/03/2007
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