Evaluation of the acceptability, safety and effectiveness of thermal ablation in the prevention of cervical neoplasia in Zimbabwe

Not Applicable

• Conditions: Cancer

• Registration Number: PACTR202103552074172
• Lead Sponsor: International Agency for Research on Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-12
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 184

Inclusion Criteria

Clinically healthy women aged 25-59 years, not pregnant, with an intact uterus and with no history of debilitating physical and mental illness
- Screen positive women with colposcopically suspected high-grade lesions (CIN 2/CIN 3) fulfilling the eligibility criteria for ablative treatment. Biopsies will be obtained from the cervical lesion(s) prior to treatment and the results will be reviewed post-treatment.
- Women with histopathologically confirmed CIN 2/3 fulfilling the eligibility criteria for ablative treatment.
- Women providing informed consent voluntarily
The eligibility criteria for ablative treatment are as follows:
- The entire squamocolumnar junction is visible and the transformation zone is of type 1
- The lesion does not occupy more than 75% of the cervix and does not extend to the endocervix or vagina
- There is no evidence of invasive cervical cancer or glandular abnormality

Exclusion Criteria

-Pregnant woman
-No histological confirmation of CIN2/CIN3
-Informed consent not provided
-Suspicion of cervical cancer
-Lesion not eligible for ablative treatment (large lesion, endocervical lesion, squamocolumnar junction not visible)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Feasibility, acceptability, safety, clinical utility and effectiveness of thermal ablation in the prevention of cervical lesions <br>- Comparison of the intensity of pain during thermal ablation between women receiving an application of local anaesthesia (lignocaine spray) and women not receiving local anaesthesia<br>- Comparison of the cure rates of lesions treated by thermal ablation at two different durations of treatment: 20 seconds and 30 seconds.

Secondary Outcome Measures

Name	Time	Method
Satisfaction level of treatment by thermal ablation.