PACTR202103552074172
Not yet recruiting
未知
Evaluation of the acceptability, safety and effectiveness of thermal ablation in the prevention of cervical neoplasia in Zimbabwe
International Agency for Research on Cancer0 sites184 target enrollmentMarch 12, 2021
ConditionsCancer
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- International Agency for Research on Cancer
- Enrollment
- 184
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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