Preventing overtreatment of CIN using methylation markers

Preventing overtreatment in CIN2/3 lesions: The role of methylation markers in predicting (non-) regression

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29301

Enrollment

200

Registered

2016-08-31

Start date

2016-12-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical intraepithelial neoplasia Overtreatment Methylation markers Regression Cervicale intraepitheliale neoplasie Overbehandeling Methylerings markers Regressie

Interventions

Standard 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 mo

Eligibility

Inclusion criteria

Inclusion criteria: In 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 criteria

Exclusion criteria: A 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

Design outcomes

Primary

Measure	Time frame
The 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.	—

Measure

Time frame

The 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.

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Secondary

Measure	Time frame
It 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.	—

Measure

Time frame

It 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.

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Contacts

Public ContactG. Kenter

Leiden University Medical Center Department of Gynaecology PO Box 9600

g.kenter@vumc.nl+31 (0)71-5263332

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)