Toluidine Blue Versus Frozen Sections for Assessment of Tumor Margins in Oral Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT03554967|
Recruitment Status : Completed
First Posted : June 13, 2018
Last Update Posted : January 23, 2020
|Condition or disease|
|Oral Squamous Cell Carcinoma|
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.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Toluidine Blue Versus Frozen Sections for Assessment of Tumor Margins in Oral Squamous Cell Carcinoma|
|Actual Study Start Date :||July 2, 2018|
|Actual Primary Completion Date :||June 3, 2019|
|Actual Study Completion Date :||June 17, 2019|
- Diagnostic accuracy of toluidine blue VS frozen section for tumor margin assessment. [ Time Frame: tumor margin will be assessed intraoperatively ]The diagnostic accuracy will be assessed by comparing the results of each technique with the final routine histopathological results.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554967
|Hana'a H Algadi|
|Principal Investigator:||Hana'a H Algadi, Msc student||Cairo University|