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Completed

NCT Number: NCT03554967

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

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.

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Key information

Conditions

Oral Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Sex eligibility

All sexes

Study type

Observational

Primary location

Hana'a H Algadi

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 13, 2018
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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