Simplified monitoring of post-treatment CIN2/3 women by molecular testing for hrHPV and methylation markers

Simplified monitoring of post-treatment CIN2/3 women by molecular testing for hrHPV and methylation markers - Simplified monitoring post-treatment

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39503

Enrollment

360

Registered

2009-12-17

Start date

2010-01-26

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

CIN premalignant cervical disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -A histological confirmed CIN2/3 lesion that will be treated by cone biopsy or colposcopic guided LLETZ. - Written informed consent prior to enrolment. - Sufficient knowledge of the Dutch language. - A minimum age of 18 years. -The intention to comply with the requirements of the protocol.

Exclusion criteria

Exclusion criteria: -The subject is pregnant (or has been in the last three months) -The subject has received prophylactic (or therapeutic) HPV- vaccination. -The subject has a diagnosis of carcinoma in cone biopsy or colposcopic guided LLETZ

Design outcomes

Primary

Measure	Time frame
The main study parameter is the histological confirmed recurrence of a high-grade lesion in the study population from the moment of treatment until exit-colposcopy	—

Secondary

Measure	Time frame
Secondary study parameters include: - In physician obtained samples: • Presence of, and if applicable type of hrHPV • Result of methylationmarker testing , i.a. CADM1/MAL • Result of cervical cytology - In self obtained samples (self-sampling): • Presence of, and if applicable type of hrHPV • Result of methylationmarker testing , i.a. CADM1/MAL - In biopsies: • Presence of, and if applicable type of hrHPV - Result of methylationmarker testing , i.a. CADM1/MAL - Results of behavioural questionnaire (including sexual behaviour, smoking and previous HPV- vaccination) - Results of questionnaire about use of self-sampling device - Histological results of all endocervical samples, biopsies, LLETZ-treatment and cold-knife conisation taken. - Result of additional immuno-staining The collection of aforementioned parameters aims to assess whether testing for methylation markers in conjunction with hrHPV testing is more effective in terms of sensitivity and specificity than cytology or a combination of hrHPV testing and cytology in detecting residual/recurrent CIN disease. In addition, we will investigate whether self-sampling provides a robust and more patient friendly approach for the detection of hrHPV and methylationtsting during post-treatment monitoring.	—

Measure

Time frame

Secondary study parameters include: - In physician obtained samples: • Presence of, and if applicable type of hrHPV • Result of methylationmarker testing , i.a. CADM1/MAL • Result of cervical cytology - In self obtained samples (self-sampling): • Presence of, and if applicable type of hrHPV • Result of methylationmarker testing , i.a. CADM1/MAL - In biopsies: • Presence of, and if applicable type of hrHPV - Result of methylationmarker testing , i.a. CADM1/MAL - Results of behavioural questionnaire (including sexual behaviour, smoking and previous HPV- vaccination) - Results of questionnaire about use of self-sampling device - Histological results of all endocervical samples, biopsies, LLETZ-treatment and cold-knife conisation taken. - Result of additional immuno-staining The collection of aforementioned parameters aims to assess whether testing for methylation markers in conjunction with hrHPV testing is more effective in terms of sensitivity and specificity than cytology or a combination of hrHPV testing and cytology in detecting residual/recurrent CIN disease. In addition, we will investigate whether self-sampling provides a robust and more patient friendly approach for the detection of hrHPV and methylationtsting during post-treatment monitoring.

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Countries

Netherlands

Outcome results