NCT03554967

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

July 2, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

11 months

First QC Date

June 1, 2018

Last Update Submit

January 21, 2020

Conditions

Oral Squamous Cell Carcinoma

Keywords

Oral Squamous Cell CarcinomaToluidine BlueFrozen SectionTumor margin assessment

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hana'a H Algadi

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 33238944DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Hana'a H Algadi, Msc student

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 1, 2018

First Posted

June 13, 2018

Study Start

July 2, 2018

Primary Completion

June 3, 2019

Study Completion

June 17, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations

EG(1)