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

NCT03137953 | Unknown

• 1 other identifier: HCG/SX/002/2016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Buccal Mucosa Cancer; Gingival Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients undergoing skin preservation surgeries

  Proportion of subjects who are to undergo skin preservation surgeries

  Data would be obtained on the day of Surgery

Study Arms (1)

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.

Procedure: Clinical Evaluation; Diagnostic Test: Radiological Imaging

Interventions

Clinical Evaluation PROCEDURE

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.

Clinical and Imaging

Radiological Imaging DIAGNOSTIC_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.

Clinical and Imaging

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• HealthCare Global Enterprise Ltd.: lead

Study Sites (1)

HealthCare Global Enterprises Ltd

Bangalore, Karnataka, 560027, India

RECRUITING

Related Publications (3)

• 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.

  PMID: 19026588 BACKGROUND

• 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.

  PMID: 16458038 BACKGROUND

• 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.

  PMID: 16529979 BACKGROUND

MeSH Terms

Interventions

Postmortem Imaging

Intervention Hierarchy (Ancestors)

Autopsy; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Investigative Techniques

Study Officials

• Vishal US Rao, MS

  Dept of Head & Neck Surgery, HealthCare Global Enterprises Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vishal US Rao, MS

CONTACT

9739774949; drvishalrao@yahoo.com

Sowjanya Gandla, MS

CONTACT

7259960602; sowjanya233@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: 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.

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: May 3, 2017
• Study Start: June 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)