N/A for Cervical dysplasia|Human papillomavirus (HPV) infection|Cervical intraepithelial neoplasia (CIN2+)

Inclusion criteria

• {"criterion_text":"- Women referred for colposcopy aged ≥ 50 years and postmenopausal."}
• {"criterion_text":"- Women referred for colposcopy due to a positive HPV test and/or an abnormal cervical cytology."}
• {"criterion_text":"- Women referred for colposcopy due to previous abnormal cervical histology with minimum 6. months since last colposcopy with biopsies."}

Exclusion criteria

• {"criterion_text":"- Women with use of estrogen within the last 3 months."}
• {"criterion_text":"- Pregnancy"}
• {"criterion_text":"- Women with previously amputation, conization or radiation of the cervix"}

Primary endpoints

• {"endpoint_text":"- Scoring of the visibility of the SCJ by the colposcopist as TZ1, TZ2 and TZ3.","definition_or_measurement_approach":"Colposcopist scores visibility of the squamocolumnar junction (SCJ) using transformation zone (TZ) classification TZ1/TZ2/TZ3."}
• {"endpoint_text":"- Representation of the TZ in at least 25% of the cervical biopsies from each patient described by the pathologist.","definition_or_measurement_approach":"Pathologist assessment of cervical biopsies to determine whether the transformation zone (TZ) is represented in at least 25% of biopsy tissue from each patient."}

Secondary endpoints

• {"endpoint_text":"- The patients' report on possible side effects during pretreatment.","definition_or_measurement_approach":"Patient-reported side effects collected during pretreatment (patient questionnaire/report)."}
• {"endpoint_text":"- The proportionen of CIN2+ found in biopsies.","definition_or_measurement_approach":"Pathology assessment of biopsy specimens to determine proportion of cases with Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+)."}
• {"endpoint_text":"- The proportion of diagnostics conization.","definition_or_measurement_approach":"Assessment of how many patients undergo diagnostic conization (proportion of participants receiving conization)."}
• {"endpoint_text":"- Explore for each patient which biopsy represent the most severe histopathologic result by comparing the first biopsy with the other three.","definition_or_measurement_approach":"Comparison of histopathologic results between the first biopsy and the other three biopsies per patient to identify which biopsy shows the most severe lesion."}

Denmark

Earliest CTIS Part Ii Submission Date

19-08-2024

Latest Decision Or Authorization Date

05-01-2026

Processing Time Days

504

Number Of Sites

4

Number Of Participants

150

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties codes: 1,8,9","organisation_type":"Educational Institution"}