NCT04809324 Gross Examinations Versus Frozen Section for Assessment of Surgical Margins in Oral Cancers
| NCT ID | NCT04809324 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dr.Pankaj Chaturvedi |
| Condition | Oral Cavity Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,206 participants |
| Start Date | 2021-11-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,206 participants in total. It began in 2021-11-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 further prospective studies are needed to explore this contentious issue (13). With this background, a prospective RCT is planned to explore if gross examination by surgeon and subsequent revision of margin (if necessary) is an equally effective alternative to Frozen section based revision in a randomized controlled trial.
Eligibility Criteria
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 -
Contact & Investigator
Pankaj Chaturvedi, MS
PRINCIPAL INVESTIGATOR
Tata Memorial Centre
Frequently Asked Questions
Who can join the NCT04809324 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Oral Cavity Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04809324 currently recruiting?
Yes, NCT04809324 is actively recruiting participants. Contact the research team at chaturvedi.pankaj@gmail.com for enrollment information.
Where is the NCT04809324 trial being conducted?
This trial is being conducted at Mumbai, India, Navi Mumbai, India, Varanasi, India.
Who is sponsoring the NCT04809324 clinical trial?
NCT04809324 is sponsored by Dr.Pankaj Chaturvedi. The principal investigator is Pankaj Chaturvedi, MS at Tata Memorial Centre. The trial plans to enroll 1,206 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.