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 |
| Secondary identifying numbers | NTR908 |
- 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
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 |
|---|---|
| t.helmerhorst@erasmusmc.nl |
Study information
| Study design | Randomised, non-controlled, parallel group, multicentre clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/07/2002 |
| Completion date | 01/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
3000 CA
Netherlands
Sponsor information
Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Obstetrics and Gynaecology
P.O. Box 2040
Rotterdam
3015 GJ
Netherlands
| Website | http://www.erasmusmc.nl/ |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Hospital/treatment centre
Erasmus Medical Centre (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
