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Clinical Trials/PACTR202103552074172
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.

Registry
who.int
Start Date
March 12, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
International Agency for Research on Cancer

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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