Post treatment cervical intraepithelial neoplasia: randomised controlled trial using high-risk human papilloma virus testing for prediction of recurrent or residual disease

ISRCTN	ISRCTN31244687
DOI	https://doi.org/10.1186/ISRCTN31244687
Protocol serial number	NTR908
Sponsor	Erasmus Medical Centre (The Netherlands)
Funder	Erasmus Medical Centre (The Netherlands)

Submission date: 06/03/2007
Registration date: 06/03/2007
Last edited: 24/12/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof T H J M Helmerhorst
Scientific

Erasmus University Medical Centre Rotterdam
Department of Obstetrics and Gynaecology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Phone	+31 (0)10 463 3381
Email	t.helmerhorst@erasmusmc.nl

Study information

Primary study design	Interventional
Study design	Randomised, non-controlled, parallel group, multicentre clinical trial
Secondary study design	Multi-centre
Scientific title
Study objectives	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.
Ethics approval(s)	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).
Health condition(s) or problem(s) studied	Post treatment CIN, cytology, high-risk HPV testing
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	1. A decrease in unnecessary examinations and treatment 2. Possible influence of high-risk HPV genotyping and effects on health-costs
Completion date	01/09/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	204
Key inclusion criteria	Women indicated to be treated for high-grade CIN lesions.
Key exclusion criteria	1. Previous treatment for high-grade CIN 2. An immune compromised state 3. Previous or current cancer
Date of first enrolment	01/07/2002
Date of final enrolment	01/09/2004

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus University Medical Centre Rotterdam

Rotterdam
3000 CA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/02/2009		Yes	No