Study comparing accuracy of two stains to mark extent of abnormal cancerous cells for better visibility during complete removal of mouth lesions.

Not Applicable

• Conditions: Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

• Registration Number: CTRI/2019/04/018537
• Lead Sponsor: Dr Gaurav Bhatia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Patients of age 18 years or above.

2) â??Oral potentially malignant disorders(OPMDs)â?? according to WHO 2017 classification.

3) Early malignant lesions i.e. Stage 1 SCC.

4) Planned for primary surgical treatment with curative intent.

5) FOR Immunohistochemistry(IHC): Wide local excision biopsy with mucosal surgical margins>=5 mm on histopathological examination.

Exclusion Criteria

1) Previous surgery, chemotherapy or radiotherapy for head and neck cancer.

2) Allergy to iodine or Toluidine blue stains.

3) Metastatic disease (except a single regional lymph node with no extracapsular spread.)

4)Patients in whom the surgical margins of the excision biopsy cannot be defined.

5)FOR Immunohistochemistry(IHC): Wide local excision biopsy specimens with surgical margins that show dysplasia, carcinoma in situ and are positive( <1 mm) and close for invasive tumour (1â??5 mm) on histopathological examination.

6) Pregnancy and lactating mothers.

7) Patients under 18 years of age.

Study & Design

• Study Type: Interventional
• Study Design: Not specified