Buccal Mucosa CancerNCT03137953
Role of Imaging to Predict the Deep Surgical Margin in Gingivobuccal Complex Tumors
A study testing Clinical Evaluation and Radiological Imaging in people with Buccal Mucosa Cancer and Gingival Cancer, run by HealthCare Global Enterprise Ltd. at 1 site in India.
Trial summary
In gingivobuccal complex tumors, the skin margin is assessed by palpation (skin pinch test). There is no objective method of assessment of skin margin. This study is to evaluate the role of computed tomography/MRI with contrast in assessing the deep surgical margin. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Buccal Mucosa Cancer, Gingival Cancer
- What is being tested?
- Clinical Evaluation and Radiological Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2016to 30 Jun 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of buccal mucosa squamous cell carcinomas of stage 1,2 and 3 are included in the study
- Patient of all age groups are included in the study
- Both males and females are included in the study
Who cannot join
- Patients with buccal mucosa carcinomas, in whom the tumour is involving/fungating through the skin.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
HealthCare Global Enterprises Ltd
Bangalore, Karnataka, 560027
Vishal US Rao, MS, 00919739774949, drvishalrao@yahoo.com
Sataksi Chatterjee, MS, 00918971966903, sataksis2007@gmail.com
About this study
In gingivobuccal complex tumors, the skin margin is assessed by palpation (skin pinch test). There is no objective method of assessment of skin margin. This study is to evaluate the role of computed tomography/MRI with contrast in assessing the deep surgical margin.
Read the detailed description
The patients of buccal mucosa squamous cell carcinomas after histopathological confirmation are selected for the study. As a routine computed tomography imaging/MRI with contrast will be done preoperatively.
The involvement of the skin is assessed by the palpation (skin pinch test). In imaging, the distance between the base of the tumour and the skin of the cheek is measured. If the distance between the base of the tumour and the skin is more than 5mm, then the skin is spared and the tumour is excised with 5 mm margin, if the distance is less than 5mm, then the skin is excised along with the tumour. The specimen will be sent for histopathological examination, and the depth of invasion of the tumour is measured and the clearance of the deep surgical margin is assessed.
The difference between clinical examination and imaging and histopathological confirmation of the specimen in determining the number of cases where skin preservation is done is assessed.
- Conditions
- Buccal Mucosa Cancer, Gingival Cancer
- Being tested
- Clinical Evaluation, Radiological Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical EvaluationProcedure or surgery
The skin pinch test would be done by three independent oncologists to assess ability for skin conservation. The decision for skin conservation would be taken by the surgeon intra-operatively based on clinical and radiological assessments.
Radiological ImagingDiagnostic test
Computed Tomography or Magnetic Resonance Imaging would be done by a radiologist and used to measure the distance between tumor and skin which would guide the decision for skin presevation. The decision for skin conservation would be taken by the surgeon intra-operatively based on clinical and radiological assessments.
| Study group | Role | What they receive |
|---|---|---|
| Clinical and Imaging | Experimental | Subjects in this arm would undergo clinical evaluation of skin involvement followed by Radiological Imaging (CT/MRI) based evaluation of the distance between the base of the tumor and the skin. Based on this distance, the skin would either be conserved or not during tumor resection. Receives: Procedure: Clinical Evaluation; Diagnostic Test: Radiological Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients undergoing skin preservation surgeries
Proportion of subjects who are to undergo skin preservation surgeries
Measured: Data would be obtained on the day of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start1 Jun 2016
- Primary completion30 Jun 2017 (estimated)
- Study completion30 Jun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Buccal Mucosa CancerStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Examination of the distance between the skin and the base of the tumour would be evaluated clinically (skin Pinch Test) and by CT/MRI with contrast. Post resection, histopathological examination of tumour margins would confirm if the base of the tumour is free or not. The proportion of cases where skin is preserved would be compared to the proportion of cases where skin would have been preserved based on clinical examination would be assessed.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthCare Global Enterprise Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Vishal U S Rao, HealthCare Global Enterprise Ltd.
- Investigators
- Vishal US Rao, MS, Principal investigator, Dept of Head & Neck Surgery, HealthCare Global Enterprises Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137953
- Sponsor's protocol ID
- HCG/SX/002/2016
- Status last verified
- May 2017
- First submitted
- 13 Feb 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ota Y, Aoki T, Karakida K, Otsuru M, Kurabayashi H, Sasaki M, Nakamura N, Kajiwara H. Determination of deep surgical margin based on anatomical architecture for local control of squamous cell carcinoma of the buccal mucosa. Oral Oncol. 2009 Jul;45(7):605-9. doi: 10.1016/j.oraloncology.2008.08.010. Epub 2008 Nov 20.
PubMed 19026588Liao CT, Wang HM, Ng SH, Yen TC, Lee LY, Hsueh C, Wei FC, Chen IH, Kang CJ, Huang SF, Chang JT. Good tumor control and survivals of squamous cell carcinoma of buccal mucosa treated with radical surgery with or without neck dissection in Taiwan. Oral Oncol. 2006 Sep;42(8):800-9. doi: 10.1016/j.oraloncology.2005.11.020. Epub 2006 Feb 2.
PubMed 16458038Coppen C, de Wilde PC, Pop LA, van den Hoogen FJ, Merkx MA. Treatment results of patients with a squamous cell carcinoma of the buccal mucosa. Oral Oncol. 2006 Sep;42(8):795-9. doi: 10.1016/j.oraloncology.2005.11.017. Epub 2006 Mar 10.
PubMed 16529979
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Imaging to Predict the Deep Surgical Margin in Gingivobuccal Complex Tumors
- ClinicalTrials.gov ID
- NCT03137953
- Acronym / sponsor ID
- HCG/SX/002/2016
- Conditions
- Buccal Mucosa Cancer, Gingival Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- HealthCare Global Enterprise Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Jun 2017 (estimated)
- Study completion
- 30 Jun 2017 (estimated)
- First posted
- 3 May 2017 (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.
In gingivobuccal complex tumors, the skin margin is assessed by palpation (skin pinch test). There is no objective method of assessment of skin margin. This study is to evaluate the role of computed tomography/MRI with contrast in assessing the deep surgical margin.
Detailed description
The patients of buccal mucosa squamous cell carcinomas after histopathological confirmation are selected for the study. As a routine computed tomography imaging/MRI with contrast will be done preoperatively.
The involvement of the skin is assessed by the palpation (skin pinch test). In imaging, the distance between the base of the tumour and the skin of the cheek is measured. If the distance between the base of the tumour and the skin is more than 5mm, then the skin is spared and the tumour is excised with 5 mm margin, if the distance is less than 5mm, then the skin is excised along with the tumour. The specimen will be sent for histopathological examination, and the depth of invasion of the tumour is measured and the clearance of the deep surgical margin is assessed.
The difference between clinical examination and imaging and histopathological confirmation of the specimen in determining the number of cases where skin preservation is done is assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Examination of the distance between the skin and the base of the tumour would be evaluated clinically (skin Pinch Test) and by CT/MRI with contrast. Post resection, histopathological examination of tumour margins would confirm if the base of the tumour is free or not. The proportion of cases where skin is preserved would be compared to the proportion of cases where skin would have been preserved based on clinical examination would be assessed.
| Arm | Type | Receives |
|---|---|---|
| Clinical and Imaging | Experimental | Procedure: Clinical Evaluation, Diagnostic Test: Radiological ImagingSubjects in this arm would undergo clinical evaluation of skin involvement followed by Radiological Imaging (CT/MRI) based evaluation of the distance between the base of the tumor and the skin. Based on this distance, the skin would either be conserved or not during tumor resection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of buccal mucosa squamous cell carcinomas of stage 1,2 and 3 are included in the study
- Patient of all age groups are included in the study
- Both males and females are included in the study
Key exclusion criteria (1 listed)
- Patients with buccal mucosa carcinomas, in whom the tumour is involving/fungating through the skin.
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 |
|---|---|---|
| Clinical EvaluationThe skin pinch test would be done by three independent oncologists to assess ability for skin conservation. The decision for skin conservation would be taken by the surgeon intra-operatively based on clinical and radiological assessments. | Procedure or surgery | Clinical and Imaging |
| Radiological ImagingComputed Tomography or Magnetic Resonance Imaging would be done by a radiologist and used to measure the distance between tumor and skin which would guide the decision for skin presevation. The decision for skin conservation would be taken by the surgeon intra-operatively based on clinical and radiological assessments. | Diagnostic test | Clinical and Imaging |
Primary outcome
Proportion of patients undergoing skin preservation surgeries
Time frame: Data would be obtained on the day of Surgery
Proportion of subjects who are to undergo skin preservation surgeries
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Background: PubMed 19026588Ota Y, Aoki T, Karakida K, Otsuru M, Kurabayashi H, Sasaki M, Nakamura N, Kajiwara H. Determination of deep surgical margin based on anatomical architecture for local control of squamous cell carcinoma of the buccal mucosa. Oral Oncol. 2009 Jul;45(7):605-9. doi: 10.1016/j.oraloncology.2008.08.010. Epub 2008 Nov 20.
- Background: PubMed 16458038Liao CT, Wang HM, Ng SH, Yen TC, Lee LY, Hsueh C, Wei FC, Chen IH, Kang CJ, Huang SF, Chang JT. Good tumor control and survivals of squamous cell carcinoma of buccal mucosa treated with radical surgery with or without neck dissection in Taiwan. Oral Oncol. 2006 Sep;42(8):800-9. doi: 10.1016/j.oraloncology.2005.11.020. Epub 2006 Feb 2.
- Background: PubMed 16529979Coppen C, de Wilde PC, Pop LA, van den Hoogen FJ, Merkx MA. Treatment results of patients with a squamous cell carcinoma of the buccal mucosa. Oral Oncol. 2006 Sep;42(8):795-9. doi: 10.1016/j.oraloncology.2005.11.017. Epub 2006 Mar 10.
- 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.
Vishal US Rao, MS principal investigator
Dept of Head & Neck Surgery, HealthCare Global Enterprises Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Evaluation and Radiological Imaging in people with Buccal Mucosa Cancer and Gingival Cancer, run by HealthCare Global Enterprise Ltd. at 1 site in India.
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: status not confirmed, as of the sponsor's last update on 9 May 2017. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vishal US Rao, MS (9739774949, drvishalrao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients undergoing skin preservation surgeries (time frame: Data would be obtained on the day of Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03137953, which also lists 3 linked publications.
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 9 May 2017.