Comparative study of frozen and gross section analysis for oral cancer patient

Performance & Early Oncological Outcomes of Intraoperative Gross Examination and Frozen Section for Oral Cavity Squamous Cell Cancer: A Phase 2 Non-Inferiority Single-Blinded Randomized Controlled Trial - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055581

Enrollment

142

Registered

2023-07-24

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C040- Malignant neoplasm of anterior floor of mouth Health Condition 2: C049- Malignant neoplasm of floor of mouth, unspecified Health Condition 3: C039- Malignant neoplasm of gum, unspecified Health Condition 4: C009- Malignant neoplasm of lip, unspecified Health Condition 5: C059- Malignant neoplasm of palate, unspecified Health Condition 6: C029- Malignant neoplasm of tongue, unspecified

Interventions

Intervention1: Frozen section analysis: Whole of surgical specimen (specimen driven method) would be sent to pathologist. They will measure the margin by standard methods. A total of five margins- Ant

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 year or old, ECOG PS: 0-2, HPE proven Oral Cavity SCC, Treatment-NaÃ¯ve, Undergoing curative resection upfront, Adequate Organ function to tolerate complete treatment.

Exclusion criteria

Exclusion criteria: Not giving consent, Salvage surgery, recurrent cancer, Non-squamous cell carcinoma histology.

Design outcomes

Primary

Measure	Time frame
1. Local recurrence free survivalTimepoint: 6 months	—

Secondary

Measure	Time frame
Performance charactersitics -Sensitivity , Specificity , Negative Predictive Value , Positive Predicitive Value & AccuracyTimepoint: 3 Weeks	—

Countries

India

Contacts

Public ContactDr Dharma Ram Poonia

All India Institute of Medical Sciences, Jodhpur

drdharmapoonia@gmail.com9958654196

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026