N87.1 D06.1
Conditions
Interventions
Group 1: The GynTect-PRO study is a prospective multicenter observational study. The observational group contains patients with histopathological confirmed CIN2 /3 lesions who have decided to pursue w
Sponsors
Universitätsklinikum Jena; Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin
Eligibility
Sex/Gender
Female
Age
18 Years to 24 Years
Inclusion criteria
Inclusion criteria: Women =18 years and ?25years with histopathologic confirmed CIN2 or CIN3. The entire lesion has to be visible by colposcopy and is free of gladular atypia. An invasive component of the lesion can be excluded with high certainty. Informed written consent.
Exclusion criteria
Exclusion criteria: Women with lesions where the entire squamous-glandular junction is not visible. Women with glandular atypia and cases in which an invasive component of the lesion cannot be excluded. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prognostic marker: Result of the GynTect® markers at the time point of diagnosis. Regression of CIN2/3 within 1 year (CIN3) and 2 years (CIN2), respectively. For CIN2 regression is defined as =CIN1 as determined by cytology or colposcopy or if unclear by histopathology. For CIN3 regression is defined as =CIN2 as determined by cytology or colposcopy or if unclear by histopathology. | — |
Secondary
| Measure | Time frame |
|---|---|
| Persistence or progression of CIN2/3 within 1 year (CIN3) and 2 years (CIN2), respectively. For CIN2 persistence and progression is defined as CIN2 or ?CIN2, respectively as determined by cytology and histopathology. For CIN3 persistence and progression is defined as CIN3 or ?CIN3, respectively as determined by cytology and histopathology. | — |
Countries
Germany
Contacts
Public ContactMatthias Dürst
Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin
Outcome results
None listed