Cervical cancer Cancer Cervical cancer
Conditions
Interventions
Examination procedure
All consented patients will be placed in a standardized lithotomy position on a gynecological couch and a self-holding speculum will be inserted in the vagina. A Pap smear and ce
Swede score: 0-10), smears, and biopsies from each group will be respectively recorded in a designated examination sheet according to clinical routine and listed in the study database protocol togethe
then on 6 monthly basis for a total of two years using cervical cytology only to detect any recurrent cervical dyskaryosis.
Examination methods:
1. VIA Method:
1.1. For women randomized to VIA, a tr
Sponsors
H&M Conscious Foundation (Sweden)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CIN 1, CIN2, CIN3, Invasive cancer, HPV, PAP smear, histopatology of punch biopsy 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. 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. 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
| Measure | Time frame |
|---|---|
| 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. 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. 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 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. | — |
Countries
Egypt
Outcome results
None listed