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

Sponsor
International Agency for Research on Cancer (Other)
Overall Status
Completed
CT.gov ID
NCT05453318
Collaborator
Referral Centre of Reproductive Health, Fez, Morocco (Other), Referral Centre of Reproductive Health, Taza, Morocco (Other)
119
Enrollment
1
Location
1
Arm
34
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Treatment of cervical neoplasia by thermal ablation
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
119 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Efficacy and Acceptability of Thermal Ablation in the Treatment of Cervical Neoplasia
Actual Study Start Date :
Oct 17, 2017
Actual Primary Completion Date :
Aug 17, 2020
Actual Study Completion Date :
Aug 17, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Cure rate based on colposcopy and histology assessment [1 year]

    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

  1. Acceptability of thermal ablation in terms of adverse events [1 year]

    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.

  2. Acceptability of thermal ablation in terms of satisfaction level [Within one hour after procedure]

    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.

  3. Safety of TA in terms of major adverse events [1 year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Referral Centre of Reproductive Health Fez Morocco

Sponsors and Collaborators

  • International Agency for Research on Cancer
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
International Agency for Research on Cancer
ClinicalTrials.gov Identifier:
NCT05453318
Other Study ID Numbers:
  • IEC/09-22
First Posted:
Jul 12, 2022
Last Update Posted:
Jul 12, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Uterine Cervical Neoplasms

Study Results

No Results Posted as of Jul 12, 2022