Clinical trial · Interventional
Role of Imaging to Predict the Deep Surgical Margin in Gingivobuccal Complex Tumors
NCT03137953CI-TRIAL-00027486unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Buccal Mucosa Cancer | — | UNRESOLVED | — |
| Gingival Cancer | Malignant Gingival Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical Evaluation | Procedure | — | UNRESOLVED |
| Radiological Imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Clinical and Imaging
- description
- 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.
- interventionNames
- Procedure: Clinical Evaluation
- Diagnostic Test: Radiological Imaging
Primary outcomes (1)
- measure
- Proportion of patients undergoing skin preservation surgeries
- timeFrame
- Data would be obtained on the day of Surgery
- description
- Proportion of subjects who are to undergo skin preservation surgeries
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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: * Patients with buccal mucosa carcinomas, in whom the tumour is involving/fungating through the skin.
References
Publications (3)
- BACKGROUNDOta 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
- BACKGROUNDLiao 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
- BACKGROUNDCoppen 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