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Study identifier: NCT04809324 Synced from ClinicalTrials.gov · July 29, 2026
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Gross Examinations Versus Frozen Section for Assessment of Surgical Margins in Oral Cancers

Condition: Oral Cavity Cancer  ·  Sponsor: Dr.Pankaj Chaturvedi

PhaseNA
Planned participants1206
Who can joinAll sexes, 18 Years to 100 Years
Healthy volunteersNo

About this study

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 patients conducted at TMH, the cost benefit ratio of FS for assessment of margin is as low as 12:1(11). In another prospective study performed at the same center , investigators found that gross examination (GE) of margins by the surgeons was as effective as FS, and achievement of gross 7mm margin all around the tumor obviated the need for FS (12). In a recent meta-analysis of 8 studies that looked at the utility of frozen section and had uniformity in frozen section analysis and definition of close margins, they concluded that revision of margins based on FS does not improve oncological outcomes and…

This description comes directly from the study's public registry record.

Talk to the study team

Pankaj Chaturvedi, MS  ·  +91 02224177189  ·  chaturvedi.pankaj@gmail.com

Vidisha V Tuljapurkar, MS MCh  ·  +91 02224177187  ·  vidishavt@yahoo.com

Always discuss trial participation with your own doctor first.

Locations (3)

Tata Memorial HospitalMumbai, Maharashtra, IndiaRecruiting
ACTREC,Advanced Centre for Treatment, Research and Education in CancerNavi Mumbai, Raigad, IndiaRecruiting
Mahamana Pandit Madan Mohan Malaviya Cancer CentreVaranasi, Uttar Pradesh, IndiaRecruiting

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Source record: clinicaltrials.gov/study/NCT04809324