Toluidine Blue Versus Frozen Sections for Assessment of Tumor Margins in Oral Squamous Cell Carcinoma

Oral Squamous Cell Carcinoma Clinical Trial

Official title:

Toluidine Blue Versus Frozen Sections for Assessment of Tumor Margins in Oral Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554967
• Other study ID #: 533
• Status: Completed
• Start date: July 2, 2018
• Est. completion date: June 17, 2019

Study information

• Verified date: January 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to test the accuracy of toluidine blue in the assessment of intraoperative tumor margin after excision of oral squamous cell carcinoma(OSCC)in comparison to H&E stain on frozen section.

Description:

The incidence of oral cancer remains high, it is ranked to be the sixth most common cancer worldwide, oral squamous cell carcinoma represent more than 90% of all oral malignances.

Standard treatment for oral squamous cell carcinoma is surgical resection with free margin. Negative margin status is an important for control local recurrence and improve outcome in squamous cell carcinoma of the head and neck. Hematoxylin and Eosin (H&E) Frozen section biopsy is useful tool for intraoperative assessment of resected margins and control of local recurrence, allowing for additional resection intraoperatively in case of positive margins. However in the least developed countries with limited resource, the frozen section is not available in a majority of centers, in addition to that if present in developed countries, it somewhat considered time and cost consumer.

Toluidine blue(TB) is metachromatic stain, easily available, economical, with high affinity for DNA and RNA. It is rapidly uptaken by malignant epithelium which contain quantitatively more nucleic acid than normal tissue. It has been widely used as screening tool for malignant and premalignant lesion.

The purpose of this study is to test the accuracy of toluidine blue in the assessment of intraoperative tumor margin after excision of oral squamous cell carcinoma(OSCC)in comparison to H&E stain on frozen section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 17, 2019
• Est. primary completion date: June 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient with biopsy-proven primary oral squamous cell carcinoma undergoing primary excision.

Exclusion Criteria:

• Patients with prior history of head and neck malignancy

• Patients with non-squamous cell carcinoma.

• Patients with previously undergone treatment (surgery and/or radio-/ chemotherapy) for the current oral squamous cell carcinoma.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Oral Squamous Cell Carcinoma

Locations

Country	Name	City	State
Egypt	Hana'a H Algadi	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of toluidine blue VS frozen section for tumor margin assessment.	The diagnostic accuracy will be assessed by comparing the results of each technique with the final routine histopathological results.	tumor margin will be assessed intraoperatively