Buccal Mucosa CancerBRUGNCT05852665
Buccal Cancer Resection Ultrasound Guided
A study testing Ultrasound-guided resection in people with Buccal Mucosa Cancer and Squamous Cell Carcinoma, run by UMC Utrecht.
Trial summary
The aim of this research is to decrease the number of inadequate tumor-free margins, probably resulting in less adjuvant therapy, less local recurrences and better quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Buccal Mucosa Cancer, Squamous Cell Carcinoma
- What is being tested?
- Ultrasound-guided resection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Mar 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- buccal mucosal squamous cell carcinoma
- surgical removal under general anesthesia
Who cannot join
- tumor is not visible on ultrasound as echolucent region
Trial locations and contacts
No sites are listed yet.
Rob Noorlag contact
About this study
Official title: Ultrasound-guided Resection of Buccal Mucosal Carcinomas - a Multicenter Study
The aim of this research is to decrease the number of inadequate tumor-free margins, probably resulting in less adjuvant therapy, less local recurrences and better quality of life.
Read the detailed description
Buccal mucosa cancer is a rare disease. In the Netherlands, approximately 100 patients are treated for this disease each year. To obtain good local control, it is important that the histological distance from the tumor to the resection plane is 5 mm or more (tumor-free margin). If the tumor-free margin is smaller, such as close (1-5 mm) or involved (<1 mm) margins, there is usually an indication for adjuvant therapy. Now, the tumor-free margins in buccal mucosa cancer are often insufficient, so that a significant proportion of patients require adjuvant treatment (re-resection or radiotherapy). Postoperative radiotherapy can greatly reduce the quality of life due to the development of, for example, osteoradionecrosis, mucositis and fibrosis. During a re-resection it is often difficult to find the location of the insufficient margin. Ultrasound-guided resection can be used to visualize the tumor during surgery, in order to improve the tumor-free margins. Currently, the tumor-free margin is only estimated palpably and frozen sections are sometimes used in case of doubt.
The aim of this research is to decrease the number of involved margins, probably resulting in less adjuvant therapy, less local recurrences, and better quality of life.
In this trial, 50 patients with a squamous cell carcinoma of the buccal mucosa will be included for treatment with ultrasound-guided resection.
50 patients with a squamous cell carcinoma of the buccal mucosa, who will be treated with surgery under general anesthesia, will be included in this study. The tumor has to be visible as an hypo-echogenic region on the ultrasound.
- Conditions
- Buccal Mucosa Cancer, Squamous Cell Carcinoma
- Being tested
- Ultrasound-guided resection
- Keywords
- Buccal mucosal carcinoma, Squamous cell carcinoma, Ultrasound, Multicenter
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided resectionDevice
Ultrasound-guided resection of buccal squamous cell carcinomas
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided surgery | Experimental | Not described Receives: Device: Ultrasound-guided resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of involved margins
Number of involved margins
Measured: within 2 weeks after surgery
Secondary outcomes (3)
Sensitivity and specificity of ultrasound for identifying involved margins
accuracy of ultrasound
Measured: within 2 weeks after surgery
Number of patients with an indication for local adjuvant therapy
need for local adjuvant treatment
Measured: within one month after surgery
Quality of life assessed by questionnaires at 4 timepoints
Influence of treatment on quality of life
Measured: before surgery, at 4, 8, and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Buccal Mucosa CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Hospital, University Medical Center Groningen, Medisch Spectrum Twente, Medical Center Haaglanden, Antoni van Leeuwenhoek Ziekenhuis
- Responsible party
- Principal investigator, Rob Noorlag, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852665
- Sponsor's protocol ID
- NL83714.041.23
- Acronym
- BRUG
- Status last verified
- May 2023
- First submitted
- 18 Apr 2023
- Last updated
- 10 May 2023
- 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 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Resection of Buccal Mucosal Carcinomas - a Multicenter Study
- ClinicalTrials.gov ID
- NCT05852665
- Acronym / sponsor ID
- BRUG / NL83714.041.23
- Conditions
- Buccal Mucosa Cancer, Squamous Cell Carcinoma
- Keywords
- Buccal mucosal carcinoma, Squamous cell carcinoma, Ultrasound, Multicenter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Rijnstate Hospital, University Medical Center Groningen, Medisch Spectrum Twente, Medical Center Haaglanden, Antoni van Leeuwenhoek Ziekenhuis
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 10 May 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.
The aim of this research is to decrease the number of inadequate tumor-free margins, probably resulting in less adjuvant therapy, less local recurrences and better quality of life.
Detailed description
Buccal mucosa cancer is a rare disease. In the Netherlands, approximately 100 patients are treated for this disease each year. To obtain good local control, it is important that the histological distance from the tumor to the resection plane is 5 mm or more (tumor-free margin). If the tumor-free margin is smaller, such as close (1-5 mm) or involved (<1 mm) margins, there is usually an indication for adjuvant therapy. Now, the tumor-free margins in buccal mucosa cancer are often insufficient, so that a significant proportion of patients require adjuvant treatment (re-resection or radiotherapy). Postoperative radiotherapy can greatly reduce the quality of life due to the development of, for example, osteoradionecrosis, mucositis and fibrosis. During a re-resection it is often difficult to find the location of the insufficient margin. Ultrasound-guided resection can be used to visualize the tumor during surgery, in order to improve the tumor-free margins. Currently, the tumor-free margin is only estimated palpably and frozen sections are sometimes used in case of doubt.
The aim of this research is to decrease the number of involved margins, probably resulting in less adjuvant therapy, less local recurrences, and better quality of life.
In this trial, 50 patients with a squamous cell carcinoma of the buccal mucosa will be included for treatment with ultrasound-guided resection.
50 patients with a squamous cell carcinoma of the buccal mucosa, who will be treated with surgery under general anesthesia, will be included in this study. The tumor has to be visible as an hypo-echogenic region on the ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided surgery | Experimental | Device: Ultrasound-guided resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- buccal mucosal squamous cell carcinoma
- surgical removal under general anesthesia
Key exclusion criteria (1 listed)
- tumor is not visible on ultrasound as echolucent region
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 |
|---|---|---|
| Ultrasound-guided resectionUltrasound-guided resection of buccal squamous cell carcinomas | Device | Ultrasound-guided surgery |
Primary outcome
Number of involved margins
Time frame: within 2 weeks after surgery
Number of involved margins
3 secondary outcomes
Sensitivity and specificity of ultrasound for identifying involved margins
Time frame: within 2 weeks after surgery
Number of patients with an indication for local adjuvant therapy
Time frame: within one month after surgery
Quality of life assessed by questionnaires at 4 timepoints
Time frame: before surgery, at 4, 8, and 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- 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.
Rob Noorlag contact
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided resection in people with Buccal Mucosa Cancer and Squamous Cell Carcinoma, run by UMC Utrecht.
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 2 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: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carleen Adriaansens, MSc (088-7567805, c.m.e.m.adriaansens-2@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of involved margins (time frame: within 2 weeks after surgery). 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 10 May 2023.