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Gross Examinations Versus Frozen Section for Assessment of Surgical Margins in Oral Cancers

RecruitingNAAges 18 Years - 100 YearsAllDr.Pankaj Chaturvedi
NCT04809324 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Surgical margin is a significant prognostic factor in oral cavity squamous cell carcinoma (OCSCC)\[1,2,3\]. Intra-operative frozen section (FS) has been routinely used by the surgeons to achieve adequate surgical margins. However published literature has failed to show a conclusive benefit of FS in improving oncological outcomes(4-7). The overall identification rate of the inadequate margins by FS is variable with figures in the literature ranging from25-34%.(8-10) Revision of margins based on FS is widely practiced in centers where facility for FS is available. However this has not shown to significantly improve local control when compared to cases in which FS was not utilized , in a comparative study done at Tata memorial Hospital(TMH) (5) More-over FS is a costly procedure, and sparsely available in resource- poor countries. In a recently conducted retrospective study of 1237 patient

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Biopsy proven treatment naïve cases of OCSCC who are planned for curative surgery with en-bloc removal of the tumor with adequate margin 2. In detail assessment of the primary tumor is possible pre-operatively 3. Written informed consent 4. Age more than 18 years Exclusion Criteria: 1. Multifocal disease 2. Clinically evident field cancerization 3. Previous treatment for oral cavity cancer - Surgery /chemo or radiotherapy -
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What it tests

  • Gross examination of the resection specimen
  • Frozen section
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Where

3 sites
Tata Memorial Hospital
Mumbai, India
ACTREC,Advanced Centre for Treatment, Research and Education in Cancer
Navi Mumbai, India
Mahamana Pandit Madan Mohan Malaviya Cancer Centre
Varanasi, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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