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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Neoplasm
• Intervention / Treatment: Procedure: Treatment of cervical neoplasia by thermal ablation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Morocco
  • Fez, Morocco
    • Referral Centre of Reproductive Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Thermal ablation Arm; Treatment of cervical neoplasia by thermal ablation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: International Agency for Research on Cancer
• Collaborators: Referral Centre of Reproductive Health, Fez, Morocco; Referral Centre of Reproductive Health, Taza, Morocco
• Investigators: Principal Investigator: Zakia GHAFFOULI, MD, Diagnosis Centre, TAZA; Principal Investigator: Hanane BELCADI ABBASSI, MD, Diagnosis Centre, Fez

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2017
• Primary Completion (ACTUAL): August 17, 2020
• Study Completion (ACTUAL): August 17, 2020

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (ACTUAL): July 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: IEC/09-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No