Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202103552074172 Date of Approval: 19/03/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of the acceptability, safety and effectiveness of thermal ablation in the prevention of cervical neoplasia in Zimbabwe
Official scientific title Evaluation of the acceptability, safety and effectiveness of thermal ablation in the prevention of cervical neoplasia in Zimbabwe
Brief summary describing the background and objectives of the trial The treatment of cervical precancerous lesions is carried out with a variety of surgical methods leading to the ablation or excision of the entire transformation zone bearing the precancerous lesions and potentially at risk for cervical neoplasia. The ablative treatment methods include cryotherapy, thermal ablation and laser. The excision treatment procedures include loop electrosurgical excision procedure, laser and cold knife. The WHO has recently recommended thermal ablation for the treatment of cervical premalignant lesions. However, there are still a few unresolved issues around the technique. The duration of application of the probe on the cervix varies from 20 to 60 seconds in various studies. The Scottish studies that till date have documented the best cure rate with thermal ablation used only 20 seconds for each application. However, the studies conducted by IARC have used 30 seconds or 45 seconds for each application. No anaesthesia is used for the procedure. At least a few (<5%) women complain of moderate to severe pain during the procedure. No study has evaluated whether the pain can be reduced by simple local anaesthetic spray. The objectives of the trial are: - To study the feasibility, acceptability, safety, clinical utility and effectiveness of thermal ablation for the treatment of cervical intraepithelial neoplasia (CIN) at Parirenyatwa Central Hospital in Zimbabwe. - To compare the intensity of pain during thermal ablation after application of local anaesthesia using lidocaine local spray with that without local anaesthesia. - To compare the cure rates of lesions treated by thermal ablation at two different durations: 20 seconds and 30 seconds of treatment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT Zimbabwe
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2021
Actual trial start date 01/06/2021
Anticipated date of last follow up 31/08/2023
Actual Last follow-up date 31/08/2023
Anticipated target sample size (number of participants) 184
Actual target sample size (number of participants) 184
Recruitment status Not yet recruiting
Publication URL -
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Thermal ablation for 30 seconds without lignocaine use N/A 30 seconds per application. Several applications may be needed according to the CIN size. The total of intervention will last less than 10 minutes. In women referred for histology confirmed CIN 2 and CIN3, treatment of the lesions by thermal ablation in applying the probe for 30 seconds per application. Several applications may be needed according to the CIN size. Immediately after treatment, the woman will answer 2 questions about the level of pain and the degree of satisfaction of the treatment. She will be invited at a 6-week, and a 12-month follow-up visits. 46
Experimental Group Thermal ablation for 20 seconds without lignocaine use N/A 20 seconds per application. Several applications may be needed according to the CIN size. The total of intervention will last less than 10 minutes In women referred for histology confirmed CIN 2 and CIN3, treatment of the lesions by thermal ablation in applying the probe for 20 seconds per application. Several applications may be needed according to the CIN size. Immediately after treatment, the woman will answer 2 questions about the level of pain and the degree of satisfaction of the treatment. She will be invited at a 6-week, and a 12-month follow-up visits. 46
Experimental Group Thermal ablation for 30 seconds with lignocaine use N/A One minute for the lignocaine spray and 30 seconds per application of thermal ablator. Several applications may be needed according to the CIN size. The total of intervention will last less than 10 minutes. In women referred for histology confirmed CIN 2 and CIN3, application of lignocaine spray on the cervix followed by treatment of the lesions by thermal ablation in applying the probe for 30 seconds per application. Several applications may be needed according to the CIN size. Immediately after treatment, the woman will answer 2 questions about the level of pain and the degree of satisfaction of the treatment. She will be invited at a 6-week, and a 12-month follow-up visits. 46
Experimental Group Thermal ablation for 20 seconds with lignocaine use N/A One minute for the lignocaine spray and 20 seconds per application of thermal ablator. Several applications may be needed according to the CIN size. The total of intervention will last less than 10 minutes In women referred for histology confirmed CIN 2 and CIN3, application of lignocaine spray on the cervix followed by treatment of the lesions by thermal ablation in applying the probe for 20 seconds per application. Several applications may be needed according to the CIN size. Immediately after treatment, the woman will answer 2 questions about the level of pain and the degree of satisfaction of the treatment. She will be invited at a 6-week, and a 12-month follow-up visits. 46
Control Group Controled group No intervention N/A N/A 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- 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 - 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) Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 59 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/02/2021 Medicines Control Authority of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
106 Baines Avenue Harare 10559 Zimbabwe
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/03/2021 IARC Ethics Committee
Ethics Committee Address
Street address City Postal code Country
105 cours Albert Thomas Lyon 69372 France
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - 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. Immediately, at 6 weeks and at 12 months after treatment
Secondary Outcome Satisfaction level of treatment by thermal ablation. Immediately after treatment.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Parirenyatwa Central Hospital Mazowe St Harare 10559 Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
International Agency for Research on Cancer 150 cours Albert Thomas Lyon 69372 France
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Agency for Research on Cancer 150 cours Albert Thomas Lyon 69372 France The specialized cancer agency of the World Health Organization
COLLABORATORS
Name Street address City Postal code Country
Parirenyatwa Central Hospital Mazowe St Harare 10559 Zimbabwe
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Partha Basu basup@iarc.fr +33472738167 150 cours Albert Thomas
City Postal code Country Position/Affiliation
Lyon 69372 France Medical Officer
Role Name Email Phone Street address
Principal Investigator Bothwell Guzha bothwellguzha@gmail.com +2630970790 11th Ave Bulawayo
City Postal code Country Position/Affiliation
Harare 10559 Zimbabwe Gynaecological Oncologist
Role Name Email Phone Street address
Public Enquiries Bothwell Guzha bothwellguzha@gmail.com +2630970790 11th Ave Bulawayo
City Postal code Country Position/Affiliation
Harare 10559 Zimbabwe Gynaecological Oncologist
Role Name Email Phone Street address
Scientific Enquiries Catherine Sauvaget sauvagetc@iarc.fr +33472738165 150 cours Albert Thomas
City Postal code Country Position/Affiliation
Lyon 69372 France Scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Not applicable. Informed Consent Form The trial is planned to start in June 2021, with a recruitment for 2 years (June 2023) and a 1-year follow-up visit. End date is expected to be in June 2024. Study report is expected to be available by the end of 2024. Investigators whose proposed use of the data for meta-analysis and sytematic review should send the direct proposal to basup@iarc.fr once the study results are published (from 2025).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 19/03/2021 To be consistent with ethics letters. Evaluation of the acceptability, safety and effectiveness of thermal ablation in the prevention of cervical neoplasia Evaluation of the acceptability, safety and effectiveness of thermal ablation in the prevention of cervical neoplasia in Zimbabwe
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 19/03/2021 To be consistent with ethics letters. Evaluation of the acceptability, safety and effectiveness of thermal ablation in the prevention of cervical neoplasia Evaluation of the acceptability, safety and effectiveness of thermal ablation in the prevention of cervical neoplasia in Zimbabwe
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 19/03/2021 Self funded by the institution. International Agency for Research on Cancer, 150 cours Albert Thomas, Lyon, 69372, France, Self Funded,