Comparison of cervical screening using visual inspection with acetic acid (VIA) with Swede score using Gynocular in detecting cervical intraepithelial Neoplasia (CIN) lesions

Completed

Conditions: Cervical cancer
Cancer

Registration Number: ISRCTN22944015

Lead Sponsor: H&M Conscious Foundation (Sweden)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 1000

Inclusion Criteria

1. Age between 25-65
2. No current significant vaginal bleeding
3. No current clinical signs of pelvic infection
4. No current clinical signs of acute cervicitis
5. More than one week since any last pelvic gynecological examination
6. Able to understand written and/or oral information
7. Mentally capable of providing informed consent

Exclusion Criteria

1. Not fulfilling any of the inclusion criteria
2. Gross cervical lesions suggestive of invasion (cancer)
3. Pregnancy
4. Less than 3 months since last delivery or miscarriage
5. Lesions involving > 75% (subjective) of the cervix are excludd from same day outpatient treatment
6. Lesions with endocervical involvement > 2mm are excluded from cold coagulation
7. Bleeding disorders
8. Sensitivity to any of the drugs/materials used

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CIN 1, CIN2, CIN3, Invasive cancer, HPV, PAP smear, histopatology of punch biopsy<br><br>1. To compare the efficacy of opportunistic screening using Gynocular and Swede scoring system, to visual inspection using acetic acid (VIA) in detecting women with cervical intraepithelial neoplasia (=CIN2) verified by histological assessment of punch biopsies. <br>2. To investigate the feasability of immediate on-site outpatient treatment using cold coagulation based on a cut-off Swede score under Gynocular inspection, or VIA positivity. <br>3. To assess the prevalence of HPV virus infection in the study cohort and the proportion and typing of high-risk HPV positive patients

Secondary Outcome Measures

Name	Time	Method
1. Receiver Operator Characteristic Curve (ROC) will be used to determine the diagnostic performance at different cut-off values of the Swede score with respect to high-grade CIN lesions.<br>2. Descriptive statistics will reflect the frequencies, proportion of high-risk HPV virus and various grades of CIN lesions in the study cohort in both arms.<br>3. To assess patient acceptance of the one-stop assessment and treatment based on the Swede score using Gynocular at the time of first examination<br>4. To examine the cost of opportunistic screening by direct event-costing, cost-effectiveness, and cost-benefit analysis comparing the different costs of the 2 study groups. This will be done when the study is completed.