Post-treatment Cervical Intraepithelial Neoplasia (CIN) Human papillomavirus (HPV) methylation markers in Dutch: Cervicale Intraepitheliale Neoplasie (CIN) Humaan papillomavirus (HPV) methyleringsmarkers follow-up
Conditions
Interventions
At time of treatment a cervical scrape will be taken for cytology testing of hrHPV and CADM1/MAL promoter methylation will be done. Six and twelve months post-treatment cervical cells will be collecte
BMD) and/or a hrHPV and methylation marker positive test in the physician obtained sample colposcopy will be performed and biopsies will be taken. At the end of the study, i.e. at thirteen months, a c
Sponsors
HumaVac (VU medical Center)
Eligibility
Inclusion criteria
Inclusion criteria: 1. A histological confirmed CIN2/3 lesion that will be treated by cone biopsy or colposcopic guided LLETZ; 2. Written informed consent prior to enrolment; 3. Sufficient knowledge of the Dutch language; 4. A minimum age of 18 years; 5. The intention to comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. The subject is pregnant (or has been in the last three months); 2. The subject has received prophylactic (or therapeutic) HPV- vaccination; 3. 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: 1. In physician obtained samples: A. Presence of, and if applicable type of hrHPV; B. Presence of DNA promoter methylation markers, as a precursor marker for high grade CIN lesions; C. Results of mRNA E6E7 transcripts; D. Result of cervical cytology. 2. In self obtained samples (self-sampling): A. Presence of, and if applicable type of hrHPV; B. Presence of DNA promoter methylation markers as a precursor marker for high grade CIN lesions; C. Results of mRNA E6E7 transcripts. 3. In biopsies: A. Presence of, and if applicable type of hrHPV; B. Presence of DNA promoter methylation markers as a precursor marker for high grade CIN lesions; C. Result of additional P16/Ki-67 Immunostaining for detection of high grade CIN lesions. 4. Results of behavioural questionnaire (including sexual behaviour, smoking and previous HPV- vaccination); 5. Results of questionnaire about use of self-sampling device; 6. Histological results of all endocervical samples, biopsies, LLETZ-treatment and cold-knife conisation taken. | — |
Contacts
Public ContactM. Kocken
VU university Medical Center room 6Z162 P.O. Box 7057
Outcome results
None listed