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Status unknownNCT03137953Updated May 9, 2017

Role of Imaging to Predict the Deep Surgical Margin in Gingivobuccal Complex Tumors

An interventional study of Clinical Evaluation and Radiological Imaging in Buccal Mucosa Cancer and Gingival Cancer, sponsored by HealthCare Global Enterprise Ltd.. Status unknown at 1 site in India. Per ClinicalTrials.gov, last updated 2017-05-09.

Sponsored by HealthCare Global Enterprise Ltd. · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jun 2016, registered Feb 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Sex
All
01

Study 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 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.

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Conditions studied

  • Buccal Mucosa Cancer
  • Gingival Cancer
03

In context

Lead sponsor

HealthCare Global Enterprise Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients with buccal mucosa carcinomas, in whom the tumour is involving/fungating through the skin.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Clinical and Imaging

    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.

    Procedure: Clinical Evaluation · Diagnostic Test: Radiological Imaging

Interventions

  • ProcedureClinical Evaluation

    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.

  • Diagnostic testRadiological Imaging

    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.

06

What researchers measure

Primary outcomes

  1. Proportion of patients undergoing skin preservation surgeries

    Proportion of subjects who are to undergo skin preservation surgeries

    Time frame: Data would be obtained on the day of Surgery

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Study locations

1 of 1 sites recruiting
  • HealthCare Global Enterprises Ltd
    Bangalore, Karnataka 560027, India
    Recruiting
    • Vishal US Rao, MS · Contactdrvishalrao@yahoo.com · 00919739774949
    • Sataksi Chatterjee, MS · Contactsataksis2007@gmail.com · 00918971966903
    • Sowjanya Gandla, MS · Sub investigator
    • Shivakumar Swamy, MD · Sub investigator
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References and documents

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 19026588 ↗
  • Liao 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 16458038 ↗
  • Coppen 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03137953
Lead sponsor
HealthCare Global Enterprise Ltd.
Responsible party
Vishal U S Rao (Senior Consultant, HealthCare Global Enterprise Ltd.) — Principal investigator
First posted
May 3, 2017
Start date
Jun 1, 2016
Primary completion
Jun 30, 2017 (estimated)
Completion
Jun 30, 2017 (estimated)
Last update
May 9, 2017

Study contacts

Vishal US Rao, MS
Contact
drvishalrao@yahoo.com
9739774949
Sowjanya Gandla, MS
Contact
sowjanya233@gmail.com
7259960602
Vishal US Rao, MS
principal investigator · Dept of Head & Neck Surgery, HealthCare Global Enterprises Ltd.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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