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

Primary Purpose

Cervical Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Morocco
Study Type
Interventional
Intervention
Treatment of cervical neoplasia by thermal ablation
Sponsored by
International Agency for Research on Cancer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Neoplasm

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Referral Centre of Reproductive Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Thermal ablation Arm

Arm Description

Treatment of cervical neoplasia by thermal ablation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 22, 2022
Last Updated
July 11, 2022
Sponsor
International Agency for Research on Cancer
Collaborators
Referral Centre of Reproductive Health, Fez, Morocco, Referral Centre of Reproductive Health, Taza, Morocco
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1. Study Identification

Unique Protocol Identification Number
NCT05453318
Brief Title
Efficacy and Acceptability of Thermal Ablation in the Treatment of Cervical Neoplasia
Official Title
Efficacy and Acceptability of Thermal Ablation in the Treatment of Cervical Neoplasia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
August 17, 2020 (Actual)
Study Completion Date
August 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Agency for Research on Cancer
Collaborators
Referral Centre of Reproductive Health, Fez, Morocco, Referral Centre of Reproductive Health, Taza, Morocco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single arm study where women presenting with cervical lesions eligible to ablation were treated and followed-up for cure and adverse events.
Masking
None (Open Label)
Allocation
N/A
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thermal ablation Arm
Arm Type
Experimental
Arm Description
Treatment of cervical neoplasia by thermal ablation
Intervention Type
Procedure
Intervention Name(s)
Treatment of cervical neoplasia by thermal ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cure rate based on colposcopy and histology assessment
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Acceptability of thermal ablation in terms of adverse events
Description
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.
Time Frame
1 year
Title
Acceptability of thermal ablation in terms of satisfaction level
Description
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.
Time Frame
Within one hour after procedure
Title
Safety of TA in terms of major adverse events
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zakia GHAFFOULI, MD
Organizational Affiliation
Diagnosis Centre, TAZA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hanane BELCADI ABBASSI, MD
Organizational Affiliation
Diagnosis Centre, Fez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Referral Centre of Reproductive Health
City
Fez
Country
Morocco

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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