Condition category
Cancer
Date applied
06/03/2007
Date assigned
06/03/2007
Last edited
24/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof T H J M Helmerhorst

ORCID ID

Contact details

Erasmus University Medical Centre Rotterdam
Department of Obstetrics and Gynaecology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 463 3381
t.helmerhorst@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR908

Study information

Scientific title

Acronym

Study hypothesis

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

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).

Study design

Randomised, non-controlled, parallel group, multicentre clinical trial

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

1. A decrease in unnecessary examinations and treatment
2. Possible influence of high-risk HPV genotyping and effects on health-costs

Overall trial start date

01/07/2002

Overall trial end date

01/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

204

Participant exclusion criteria

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

Recruitment start date

01/07/2002

Recruitment end date

01/09/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus University Medical Centre Rotterdam
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

Department of Obstetrics and Gynaecology
P.O. Box 2040
Rotterdam
3015 GJ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19048594

Publication citations

  1. Results

    Bais AG, Eijkemans MJ, Rebolj M, Snijders PJ, Verheijen RH, van Ballegooijen M, Meijer CJ, Helmerhorst TJ, Post-treatment CIN: randomised clinical trial using hrHPV testing for prediction of residual/recurrent disease., Int. J. Cancer, 2009, 124, 4, 889-895, doi: 10.1002/ijc.23824.

Additional files

Editorial Notes