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Search / Trial NCT04809324

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

Launched by DR.PANKAJ CHATURVEDI · Mar 19, 2021

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

Oral Squamous Cell Carcinoma Frozen Section Local Recurrence

ClinConnect Summary

This clinical trial is studying two different methods for checking the edges of tumors in patients with oral cavity cancer to see which method is more effective. The two methods being compared are gross examination (where the surgeon visually inspects the area) and frozen section (a lab test that looks at the tissue immediately during surgery). The goal is to find out if the surgeon's visual inspection is just as good as the lab test for ensuring that all the cancer has been removed. Previous studies have shown that the frozen section may not significantly improve patient outcomes and can be expensive and hard to access in some places.

To participate in this trial, you need to be an adult over 18 years old with a confirmed diagnosis of oral cavity cancer who has not received any prior treatment. You should be scheduled for surgery to remove the tumor with a clear margin, meaning there’s healthy tissue around it. If you join the trial, you can expect to have your surgical margins assessed through either method, and researchers will monitor the outcomes to see which approach works best. This study is currently recruiting participants, and your involvement could help improve treatment strategies for future patients with oral cavity cancer.

Gender

ALL

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 -

About Dr.Pankaj Chaturvedi

Dr. Pankaj Chaturvedi is a prominent clinical trial sponsor known for his commitment to advancing medical research and improving patient outcomes. With extensive expertise in oncology and a focus on innovative therapeutic strategies, Dr. Chaturvedi leads rigorous clinical trials that aim to evaluate new treatments and enhance existing protocols. His dedication to ethical standards and patient safety ensures that trials are conducted with the highest level of integrity, fostering collaboration among multidisciplinary teams. Through his initiatives, Dr. Chaturvedi contributes significantly to the development of effective healthcare solutions and the advancement of clinical science.

Locations

Mumbai, Maharashtra, India

Navi Mumbai, Raigad, India

Varanasi, Uttar Pradesh, India

Patients applied

0 patients applied

Trial Officials

Pankaj Chaturvedi, MS

Principal Investigator

Tata Memorial Centre

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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