Cervical NeoplasmNCT05453318
Efficacy and Acceptability of Thermal Ablation in the Treatment of Cervical Neoplasia
A study testing Treatment of cervical neoplasia by thermal ablation in people with Cervical Neoplasm, run by International Agency for Research on Cancer at 1 site in Morocco.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Cervical Neoplasm
- What is being tested?
- Treatment of cervical neoplasia by thermal ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteMorocco
- Study dates
- 17 Oct 2017to 17 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cervical Neoplasm
- Being tested
- Treatment of cervical neoplasia by thermal ablation
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of cervical neoplasia by thermal ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Thermal ablation Arm | Experimental | Treatment of cervical neoplasia by thermal ablation Receives: Procedure: Treatment of cervical neoplasia by thermal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 1 year
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.
Measured: Within one hour after procedure
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start17 Oct 2017
- Primary completion17 Aug 2020
- Study completion17 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- Referral Centre of Reproductive Health, Fez, Morocco, Referral Centre of Reproductive Health, Taza, Morocco
- Responsible party
- Sponsor
- Investigators
- Zakia GHAFFOULI, MD, Principal investigator, Diagnosis Centre, TAZAHanane BELCADI ABBASSI, MD, Principal investigator, Diagnosis Centre, Fez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453318
- Sponsor's protocol ID
- IEC/09-22
- Status last verified
- Jun 2022
- First submitted
- 22 Jun 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Acceptability of Thermal Ablation in the Treatment of Cervical Neoplasia
- ClinicalTrials.gov ID
- NCT05453318
- Acronym / sponsor ID
- IEC/09-22
- Conditions
- Cervical Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Collaborators
- Referral Centre of Reproductive Health, Fez, Morocco, Referral Centre of Reproductive Health, Taza, Morocco
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 17 Aug 2020 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Thermal ablation Arm | Experimental | Procedure: Treatment of cervical neoplasia by thermal ablationTreatment of cervical neoplasia by thermal ablation |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of cervical neoplasia by thermal ablationWomen 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. | Procedure or surgery | Thermal ablation Arm |
Primary outcome
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.
3 secondary outcomes
Acceptability of thermal ablation in terms of adverse events
Time frame: 1 year
Acceptability of thermal ablation in terms of satisfaction level
Time frame: Within one hour after procedure
Safety of TA in terms of major adverse events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zakia GHAFFOULI, MD principal investigator
Diagnosis Centre, TAZA
Hanane BELCADI ABBASSI, MD principal investigator
Diagnosis Centre, Fez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of cervical neoplasia by thermal ablation in people with Cervical Neoplasm, run by International Agency for Research on Cancer at 1 site in Morocco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate based on colposcopy and histology assessment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.