Efficacy and Acceptability of Thermal Ablation in the Treatment of Cervical Neoplasia

Cervical Neoplasm Clinical Trial

Official title:

Efficacy and Acceptability of Thermal Ablation in the Treatment of Cervical Neoplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05453318
• Other study ID #: IEC/09-22
• Status: Completed
• Phase: N/A
• Start date: October 17, 2017
• Est. completion date: August 17, 2020

Study information

• Verified date: June 2022
• Source: International Agency for Research on Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The study population consisted of women with a positive Visual Inspection with Acetic Acid (VIA) screening test referred for ablative treatment. A total of 119 women with lesions eligible to ablative treatment were counselled and treated by thermal ablation. Informed consent was signed by each participant. Just after treatment, the patients were inquired about the level of pain during the procedure, and their level of satisfaction with the treatment. The women were followed-up at 6 weeks for any complication and re-assessed by colposcopy and biopsy at 12 months for any persistent or recurrent lesion and for any adverse event.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cervical Neoplasm
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Treatment of cervical neoplasia by thermal ablation
Women screened for cervical cancer by VIA presenting lesions eligible for ablative treatment were treated by thermal ablation. The treatment consisted in applying the probe on the lesion for 45 seconds at 100 degrees Celsius, with one to up to five applications depending on the lesion size. Following treatment, women were inquired about the pain level during the procedure, their satisfaction level of the procedure and whether they would recommend this treatment to their relatives. Women had a follow-up visit at 6 weeks to assess any complication of the procedure. Women were rescreened at 12 months, to evaluate the cure rate and any long-term adverse events.

Locations

Country	Name	City	State
Morocco	Referral Centre of Reproductive Health	Fez

Sponsors (3)

Lead Sponsor	Collaborator
International Agency for Research on Cancer	Referral Centre of Reproductive Health, Fez, Morocco, Referral Centre of Reproductive Health, Taza, Morocco

Country where clinical trial is conducted

Morocco, 

Outcome

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