Toluidine Blue Versus Frozen Sections for Assessment of Tumor Margins in Oral Squamous Cell Carcinoma
NCT ID: NCT03554967
Last Updated: 2020-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2018-07-02
2019-06-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
OTHER
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with non-squamous cell carcinoma.
* Patients with previously undergone treatment (surgery and/or radio-/ chemotherapy) for the current oral squamous cell carcinoma.
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Hana'a Hezam Ghaleb Algadi
principal investigator
Principal Investigators
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Hana'a H Algadi, Msc student
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Hana'a H Algadi
Cairo, , Egypt
Countries
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References
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Algadi HH, Abou-Bakr AA, Jamali OM, Fathy LM. Toluidine blue versus frozen section for assessment of mucosal tumor margins in oral squamous cell carcinoma. BMC Cancer. 2020 Nov 25;20(1):1147. doi: 10.1186/s12885-020-07644-0.
Other Identifiers
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533
Identifier Type: -
Identifier Source: org_study_id
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