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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
Sponsor:
Information provided by (Responsible Party):
Hana'a Hezam Ghaleb Algadi, Cairo University

Brief 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.

Condition or disease
Oral Squamous Cell Carcinoma

Detailed 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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Other
Time Perspective: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with biopsy-proven primary oral squamous cell carcinoma undergoing primary excision.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Egypt
Hana'a H Algadi
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Hana'a H Algadi, Msc student Cairo University

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Responsible Party: Hana'a Hezam Ghaleb Algadi, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03554967    
Other Study ID Numbers: 533
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hana'a Hezam Ghaleb Algadi, Cairo University:
Oral Squamous Cell Carcinoma
Toluidine Blue
Frozen Section
Tumor margin assessment
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Tolonium Chloride
Hemostatics
Coagulants
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action