Cervical Intraepithelial Neoplasia, Cervical Lesion, Human Papillomavirus Cervicale Intraepitheliale Neoplasie, Humaan Papillomavirus
Conditions
Interventions
Not applicable. This is an observational study which follows the regular clinical procedures.
Sponsors
Performers:
- DDL Diagnostic Laboratory, Rijswijk, The Netherlands
- Reinier de Graaf Groep, Delft, The Netherlands
- Hospital Clinic, Barcelona, Spain
Eligibility
Inclusion criteria
Inclusion criteria: 1. An abnormal cytological test result; 2. 18 years of age or older; 3. Written informed consent prior to enrolment; 4. Sufficient knowledge of the Dutch/Spanish language; 5. The intention to comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. History of surgery on the cervix; 2. Previous pelvic radiotherapy; 3. Pregnancy or pregnant in the last 3 months; 4. Actually breast-feeding or breast-feeding in the last 3 months; 5. Diagnosis of cervix carcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In the follow-up period of the study, the endpoint will be the histologically confirmed recurrence of a high-grade cervical lesion, defined as CIN 2 or 3, AIS or worse, or after the colposcopic examination 24 months after the first visit has been performed. | — |
Contacts
Public ContactJ. Marel, van der
DDL Diagnostic Laboratory Visseringlaan 25
Outcome results
None listed