Oral Squamous Cell CarcinomaNCT03554967
Toluidine Blue Versus Frozen Sections for Assessment of Tumor Margins in Oral Squamous Cell Carcinoma
An observational study of Oral Squamous Cell Carcinoma, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Squamous Cell Carcinoma
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jul 2018to 17 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with biopsy-proven primary oral squamous cell carcinoma undergoing primary excision.
Who may be able to join
- Patient with biopsy-proven primary oral squamous cell carcinoma undergoing primary excision.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Oral Squamous Cell Carcinoma
- Keywords
- Oral Squamous Cell Carcinoma, Toluidine Blue, Frozen Section, Tumor margin assessment
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: tumor margin will be assessed intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start2 Jul 2018
- Primary completion3 Jun 2019
- Study completion17 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hana'a Hezam Ghaleb Algadi, Cairo University
- Investigators
- Hana'a H Algadi, Msc student, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554967
- Sponsor's protocol ID
- 533
- Status last verified
- Jan 2020
- First submitted
- 1 Jun 2018
- Last updated
- 23 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33238944
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toluidine Blue Versus Frozen Sections for Assessment of Tumor Margins in Oral Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03554967
- Acronym / sponsor ID
- 533
- Conditions
- Oral Squamous Cell Carcinoma
- Keywords
- Oral Squamous Cell Carcinoma, Toluidine Blue, Frozen Section, Tumor margin assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 17 Jun 2019 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with biopsy-proven primary oral squamous cell carcinoma undergoing primary excision.
Key inclusion criteria (1 listed)
- Patient with biopsy-proven primary oral squamous cell carcinoma undergoing primary excision.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Derived from this study: PubMed 33238944Algadi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hana'a H Algadi, Msc student principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Squamous Cell Carcinoma, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of toluidine blue VS frozen section for tumor margin assessment. (time frame: tumor margin will be assessed intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03554967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.