Evaluating Thermal Ablation in the Treatment of Cervical Neoplasia

NCT05211271 | Completed

• 1 other identifier: FM/CE/05/08/2018
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Longitudinal study in Burundi to evaluate the effectiveness, the acceptability and safety of thermal ablation in the treatment of cervical neoplasia.

Conditions

Cervical Neoplasia

Keywords

cervical neoplasia; treatment; thermal ablation; longitudinal study; LMIC

Outcome Measures

Primary Outcomes (4)

• Cure rate based on VIA and colposcopy assessment

  Effectiveness is measured by the cure rate after 1 year based on VIA and colposcopy assessment.

  1 year

• Acceptability of thermal ablation

  Measured by existence of minor/moderate adverse events during the follow-up.

  6 weeks

• Acceptability of thermal ablation

  Measured by the satisfaction level using a nine-level Likert scale (from 1. Very unsatisfied to 9. very satisfied).

  At day 1

• Safety of thermal ablation

  Measured by existence of severe adverse events during the follow-up period.

  1 year

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Treatment of cervical neoplasia by thermal ablation

Device: Treatment of cervical neoplasia by thermal ablation

Interventions

Treatment of cervical neoplasia by thermal ablation DEVICE

Women screened for cervical cancer by visual inspection with diluted acetic acid (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.

Intervention Arm

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women residing in Burundi and referred to the tertiary hospital after a positive VIA test

You may not qualify if:

• Lesion occupying the 4 quadrants of the cervix
• Not visible squamous columnar junction (not Type 1 TZ)
• Vaginal or endocervical lesion
• Lesion subjective of cervical cancer

Sponsors & Collaborators

• International Agency for Research on Cancer: lead
• Kamenge University Hospital, Burundi University, Burundi: collaborator

Study Sites (1)

Kamenge University Hospital

Bujumbura, 2210, Burundi

Location

Related Publications (1)

• Sauvaget C, Bazikamwe S, Lucas E, Ndayikengurukiye A, Harerimana S, Barango P. Evaluation of effectiveness, acceptability and safety of thermal ablation in the treatment of cervical neoplasia in Burundi. Int J Cancer. 2022 Oct 1;151(7):1120-1126. doi: 10.1002/ijc.34117. Epub 2022 Jun 3.

  PMID: 35567576 RESULT

Study Officials

• Sylvestre Bazikamwe, MD

  Kamenge University Hospital, Burundi University, Bujumbura, Burundi

  PRINCIPAL INVESTIGATOR

• Catherine Sauvaget, MD, PhD

  International Agency for Research on Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 27, 2022
• Study Start: October 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 2, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)