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NCT Number: NCT05453318

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.

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Key information

Conditions

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

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Referral Centre of Reproductive Health

Fes, Morocco

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Cure rate based on colposcopy and histology assessment

    Time frame: 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 outcomes

  1. Acceptability of thermal ablation in terms of adverse events

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

International Agency for Research on Cancer

Other

Collaborators

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

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 12, 2022
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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