Craniofacial Fibrous DysplasiaCFDNCT06167122
Treatment Protocol and Long-Term Outcomes in Craniofacial Fibrous Dysplasia
An observational study of Craniofacial Fibrous Dysplasia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Craniofacial fibrous dysplasia (CFD) is a nonneoplastic disease characterized by fibro-osseous lesions in the affected bones. Treatment is mainly surgical and is stratified based on four different anatomical zones. This study aimed to evaluate the long-term outcomes and refine the algorithm for CFD. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Craniofacial Fibrous Dysplasia
- What is being tested?
- Craniofacial reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2020to 14 Mar 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patient with craniofacial fibrous dysplasia, and received craniofacial surgery
Who may be able to join
- Received CFD surgical intervention between 1972 and 2019
- Personal interviews: between late 2019 and 2020, covering a postoperative period of over 20 years
- All the surgery were performed by a senior surgeon (Yu-Ray Chen) at Chang Gung Craniofacial Center
Who cannot join
- Patients who underwent surgical treatment at other institutions during the follow-up period or those who did not return to the craniofacial outpatient department for follow-up and receive computed tomography scans between 2019 and 2020 will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Follow-up and Treatment Protocol for Craniofacial Fibrous Dysplasia From 40-year Data at Chang Gung Memorial Hospital: A Retrospective Case Series
Craniofacial fibrous dysplasia (CFD) is a nonneoplastic disease characterized by fibro-osseous lesions in the affected bones. Treatment is mainly surgical and is stratified based on four different anatomical zones. This study aimed to evaluate the long-term outcomes and refine the algorithm for CFD.
Read the detailed description
According to Chen et. al for the appropriate surgical management of FD the craniofacial skeleton can be divided into four zones according to the consideration of facial cosmesis, vital anatomical region and function preserving. The aim of the study was to evaluate the outcome of nearly 40 years long-term follow up cohort group and refine the algorithm of surgical intervention of FD under 4 zones classification.
- Conditions
- Craniofacial Fibrous Dysplasia
- Being tested
- Craniofacial reconstruction
- Keywords
- Craniofacial fibrous dysplasia, Optic nerve decompression, Hormone therapy
- Medical subject headings
- Craniofacial Fibrous Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Craniofacial reconstructionProcedure or surgery
Zone 1 lesions: radical excision and immediate reconstruction with bone grafts for fibrous dysplasia lesions.
Zone 2 lesions: trimming \& recontouring. Zone 3 lesions: observation or conservative recontouring; optic nerve decompression performed when continuous deterioration of vision, and external auditory canal surgery performed when cholesteatoma/near total ear canal stenosis.
Zone 4: observation or conservative recontouring; orthognathic surgery performed when malocclusion or midface retrusion noted.
| Study group | Role | What they receive |
|---|---|---|
| Craniofacial fibrous dysplasia | Fibro-osseous lesions within the affected bones based on image, and surgical intervention based on 4 different anatomical zones. Receives: Procedure: Craniofacial reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Recurrence based on facial bone computed tomography
Measured: Personal interviews with facial bone computed tomography obtained on late 2019 and 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Mar 2020
- Primary completion10 Feb 2021
- Study completion14 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniofacial Fibrous DysplasiaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pangyunchou, Chang Gung Memorial Hospital
- Investigators
- Pang-Yun Chou, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167122
- Sponsor's protocol ID
- 202000158B0
- Acronym
- CFD
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up and Treatment Protocol for Craniofacial Fibrous Dysplasia From 40-year Data at Chang Gung Memorial Hospital: A Retrospective Case Series
- ClinicalTrials.gov ID
- NCT06167122
- Acronym / sponsor ID
- CFD / 202000158B0
- Conditions
- Craniofacial Fibrous Dysplasia
- Keywords
- Craniofacial fibrous dysplasia, Optic nerve decompression, Hormone therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 14 Mar 2021 (actual)
- First posted
- 12 Dec 2023 (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.
Craniofacial fibrous dysplasia (CFD) is a nonneoplastic disease characterized by fibro-osseous lesions in the affected bones. Treatment is mainly surgical and is stratified based on four different anatomical zones. This study aimed to evaluate the long-term outcomes and refine the algorithm for CFD.
Detailed description
According to Chen et. al for the appropriate surgical management of FD the craniofacial skeleton can be divided into four zones according to the consideration of facial cosmesis, vital anatomical region and function preserving. The aim of the study was to evaluate the outcome of nearly 40 years long-term follow up cohort group and refine the algorithm of surgical intervention of FD under 4 zones classification.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Craniofacial fibrous dysplasia | – | Procedure: Craniofacial reconstructionFibro-osseous lesions within the affected bones based on image, and surgical intervention based on 4 different anatomical zones. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with craniofacial fibrous dysplasia, and received craniofacial surgery
Key inclusion criteria (3 listed)
- Received CFD surgical intervention between 1972 and 2019
- Personal interviews: between late 2019 and 2020, covering a postoperative period of over 20 years
- All the surgery were performed by a senior surgeon (Yu-Ray Chen) at Chang Gung Craniofacial Center
Key exclusion criteria (1 listed)
- Patients who underwent surgical treatment at other institutions during the follow-up period or those who did not return to the craniofacial outpatient department for follow-up and receive computed tomography scans between 2019 and 2020 will be excluded.
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 |
|---|---|---|
| Craniofacial reconstructionZone 1 lesions: radical excision and immediate reconstruction with bone grafts for fibrous dysplasia lesions. Zone 2 lesions: trimming \& recontouring. Zone 3 lesions: observation or conservative recontouring; optic nerve decompression performed when continuous deterioration of vision, and external auditory canal surgery performed when cholesteatoma/near total ear canal stenosis. Zone 4: observation or conservative recontouring; orthognathic surgery performed when malocclusion or midface retrusion noted. | Procedure or surgery | Craniofacial fibrous dysplasia |
Primary outcome
Recurrence
Time frame: Personal interviews with facial bone computed tomography obtained on late 2019 and 2020
Recurrence based on facial bone computed tomography
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 Dec 2023.
- Individual participant dataSharing planned: No
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Recruiting
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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.
Pang-Yun Chou principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniofacial Fibrous Dysplasia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 1 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 Dec 2023. 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 Taiwan. 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?
Recurrence (time frame: Personal interviews with facial bone computed tomography obtained on late 2019 and 2020). 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 Dec 2023.