Cervical Neoplasm Clinical Trial
Official title:
Efficacy and Acceptability of Thermal Ablation in the Treatment of Cervical Neoplasia
Verified date | June 2022 |
Source | International Agency for Research on Cancer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Longitudinal study in two referral centers in Morocco to evaluate the effectiveness, the acceptability and safety of thermal ablation in the treatment of cervical neoplasia.
Status | Completed |
Enrollment | 119 |
Est. completion date | August 17, 2020 |
Est. primary completion date | August 17, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 50 Years |
Eligibility | Inclusion Criteria: - Women having been screened positive at VIA at the primary health center and referred to the diagnosis centre of Fez and Taza for ablative treatment by thermal ablation Exclusion Criteria: - Lesion occupying the 4 quadrants of the cervix - Not visible squamous columnar junction (not Type 1 TZ (transformation zone)) - Vaginal or endocervical lesion - Lesion subjective of cervical cancer |
Country | Name | City | State |
---|---|---|---|
Morocco | Referral Centre of Reproductive Health | Fez |
Lead Sponsor | Collaborator |
---|---|
International Agency for Research on Cancer | Referral Centre of Reproductive Health, Fez, Morocco, Referral Centre of Reproductive Health, Taza, Morocco |
Morocco,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cure rate based on colposcopy and histology assessment | Cure rate is assessed after 1 year of treatment by colposcopy. Persistent or recurrent lesions are treated by thermal ablation, excision or hysterectomy according to the lesion size and characteristics. | 1 year | |
Secondary | Acceptability of thermal ablation in terms of adverse events | Information on adverse events are collected immediately after the treatment, at the 6-week visit (short-term adverse events) and at the 12-month visit. Any minor and moderate complications are inquired. | 1 year | |
Secondary | Acceptability of thermal ablation in terms of satisfaction level | Acceptability of thermal ablation is also measured by the satisfaction levelusing a nine-level Likert scale (from 1. Very unsatisfied to 9. Verysatisfied), through administration of a questionnaire just after treatment. | Within one hour after procedure | |
Secondary | Safety of TA in terms of major adverse events | Information on adverse events are collected immediately after the treatment, at the 6-week visit (short-term adverse events) and at the 12-month visit. Any major complications (i.e. necessitating hospitalization) were inquired. | 1 year |
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