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

• Register: PACTR
• Last refreshed on: 30 August 2021
• Main ID: PACTR202103552074172
• Date of registration: 12/03/2021
• Prospective Registration: Yes
• Primary sponsor: International Agency for Research on Cancer
• Public title: Evaluation of the acceptability, safety and effectiveness of thermal ablation in the prevention of cervical neoplasia in Zimbabwe
• Scientific title: Evaluation of the acceptability, safety and effectiveness of thermal ablation in the prevention of cervical neoplasia in Zimbabwe
• Date of first enrolment: 01/06/2021
• Target sample size: 184
• Recruitment status: Pending
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=15741
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomization using a randomization table created by a computer software program,Sealed opaque envelopes
• Phase: Not Applicable

Countries of recruitment

Zimbabwe

Contacts

• Name: Bothwell Guzha
• Affiliation: Gynaecological Oncologist

• Name: Catherine Sauvaget
• Affiliation: Scientist

Key inclusion & exclusion 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)


Age minimum: 19 Year(s)
Age maximum: 44 Year(s)
Gender: Female

Health Condition(s) or Problem(s) studied

Cancer

Cancer

Intervention(s)

Controled group

Thermal ablation for 20 seconds with lignocaine use

Thermal ablation for 20 seconds without lignocaine use

Thermal ablation for 30 seconds with lignocaine use

Thermal ablation for 30 seconds without lignocaine use

Primary Outcome(s)

- Feasibility, acceptability, safety, clinical utility and effectiveness of thermal ablation in the prevention of cervical lesions
- 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
- Comparison of the cure rates of lesions treated by thermal ablation at two different durations of treatment: 20 seconds and 30 seconds.

Secondary Outcome(s)

Satisfaction level of treatment by thermal ablation.

Source(s) of Monetary Support

International Agency for Research on Cancer

Ethics review

Status: Approved
Approval date: 15/02/2021
Contact:

[e-mail]

Medicines Control Authority of Zimbabwe

[phone]

[e-mail]

Status: Approved
Approval date: 04/03/2021
Contact:

[e-mail]

IARC Ethics Committee

[phone]

[e-mail]