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Preventing overtreatment of CIN using methylation markers


- candidate number25240
- NTR NumberNTR6069
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-aug-2016
- Secondary IDsNL56187.029.16 
- Public TitlePreventing overtreatment of CIN using methylation markers
- Scientific TitlePreventing overtreatment in CIN2/3 lesions: The role of methylation markers in predicting (non-) regression
- ACRONYMCONCERVE
- hypothesisAnalysis of methylation status can predict which CIN2/3 lesions will regress and which not, determining the need of immediate treatment versus active surveillance.
- Healt Condition(s) or Problem(s) studiedCervical intraepithelial neoplasia (CIN), Overtreatment, Methylation markers
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria:
- CIN2 or CIN3 on a cervical punch biopsy
- CIN covering 50% or less of the visible cervix
- Female aged 18-55 years
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
- History of cervical pathology
- Transformation zone is not visible at colposcopy
- Prenatal diethylstilboestrol exposure
- Concomitant cancer
- Insufficient Dutch or English language skills
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2016
- planned closingdate30-nov-2019
- Target number of participants150
- InterventionsStandard therapy for CIN2/3 lesions consists of excision of the lesion by either LLETZ or cold knife conisation. In this study, treatment consists of a watchful waiting policy. Participants will be monitored by an intense follow-up schedule consisting of 6-monthly visits to the colposcopy clinic for 2 years. During these visits, cervical cytology, hrHPV testing, methylation marker analysis and colposcopic evaluation of the cervix will be performed.
- Primary outcomeThe primary study endpoint is (non-) regression at the end of the study based on histology of the cervical exit biopsy. All cervical biopsies will be examined by a gynaeco-pathologist and classified as no CIN, CIN1, CIN2, CIN3 or cervical carcinoma. Regression is defined as CIN1 or less on the exit biopsy based on morphology. Non-regression is defined as CIN2+ on the exit biopsy based on morphology.
- Secondary outcomeIt has been shown that HPV-clearance precedes regression of cervical lesions by an average of 3 months. Therefore, the secondary study endpoint is defined as HPV clearance (double negative hrHPV test at two consecutive time points). HPV DNA detection will be done with the clinically validated HPV-Risk assay, a multiplex real-time PCR-based assay designed for the clinical detection of high-risk HPV DNA of 15 (probably) high-risk HPV types (i.e. HPV16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68). This assay detects HPV 16 and 18 in separate channels, and the other HPV types as a pool.
- TimepointsBaseline, 6, 12, 18, 24 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. G. Kenter
- CONTACT for SCIENTIFIC QUERIESProf. Dr. G. Kenter
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryCurrent cytology-based cervical screening programmes serve to detect and treat high-grade precursor lesions (CIN2/3) to prevent cervical cancer. However, the diagnostic-treatment trajectory is associated with considerable overtreatment since CIN2/3 lesions, particularly in young women, have a high spontaneous regression rate. Pathologists are unable to differentiate between CIN2/3 lesions with a low short-term progression risk to cervical cancer (productive lesions), not in need of immediate treatment, and those with a high short-term progression risk (transforming lesions) that need immediate treatment. Individual cancer risk prediction of CIN2/3 is therefore essential to reduce overtreatment. Recently, it has been shown that DNA methylation markers can differentiate between productive and transforming CIN2/3. Here, we aim to validate prospectively that testing for the methylation status of a CIN2/3 predicts (non-) regression leading to prevention of overtreatment.
- Main changes (audit trail)
- RECORD31-aug-2016 - 3-nov-2016


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