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

NCT05453318 | Completed

• 1 other identifier: IEC/09-22
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Acceptability of thermal ablation in terms of adverse events

  1 year

• Acceptability of thermal ablation in terms of satisfaction level

  Within one hour after procedure

• Safety of TA in terms of major adverse events

  1 year

Study Arms (1)

Thermal ablation Arm

EXPERIMENTAL

Treatment of cervical neoplasia by thermal ablation

Procedure: Treatment of cervical neoplasia by thermal ablation

Interventions

Treatment of cervical neoplasia by thermal ablation PROCEDURE

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.

Thermal ablation Arm

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Agency for Research on Cancer: lead
• Referral Centre of Reproductive Health, Fez, Morocco: collaborator
• Referral Centre of Reproductive Health, Taza, Morocco: collaborator

Study Sites (1)

Referral Centre of Reproductive Health

Fes, Morocco

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Zakia GHAFFOULI, MD

  Diagnosis Centre, TAZA

  PRINCIPAL INVESTIGATOR

• Hanane BELCADI ABBASSI, MD

  Diagnosis Centre, Fez

  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

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 12, 2022
• Study Start: October 17, 2017
• Primary Completion: August 17, 2020
• Study Completion: August 17, 2020
• Last Updated: July 12, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)