high-grade cervical intraepithelial neoplasia
Conditions
Interventions
Participating women will receive a user-friendly self-sampling package by
regular mail in order to collect a cervico-vaginal specimen. These specimens
will be send to the Vumc and tested for the pre
i.e. women
with high gradeCIN lesions will be treated and those with less severe lesions
will undergo follow-up cytology and colposcopy at 6 months.
All procedures at the gynaecologist will be in
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Female -Age 20-70 -Previous two Pap smears read as bordeline/mild dyskaryosis (Pap2/3a1) or previous single Pap smear read as moderate dyskaryosis or worse (*Pap3a2) -Intact cervix (no history of treatment involving damage to the transformation zone of the cervix) - Sufficient knowledge of the Dutch language. - Able to understand the content of the study (according to the gynecologist). - Signed informed consent form.
Exclusion criteria
Exclusion criteria: -Pap smear read as Pap 5 (suspect for invasive cancer) -Cancer at other sites -Withdrawal of permission by the patient -History of surgery on the cervix -Pregnancy or pregnant in the last 3 months. -Breast-feeding, or breast-feeding in the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the frequency of CIN3 in two study populations, i.e. women who test positive for hrHPV and TSLC1 compared with women who test negative for either or both hrHPV and TSLC1. | — |
Secondary
| Measure | Time frame |
|---|---|
| As one of the secondary parameters it will be assessed whether the CIN3 lesions are advanced lesions. This will be evaluated by measuring the size of the lesions using colposcopic imaging and the status of molecular markers for advanced CIN3 (a.o. elevated hTERT mRNA expression levels) in the lesions. | — |
Countries
Netherlands
Outcome results
None listed