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Tumor immune infiltrates as prognostic biomarkers in oral cancer

Assessment of Tumor Infiltrating Lymphocytes, Tumor Associated Macrophages and Natural Killer Cells as Prognostic Biomarkers in Oral Squamous Cell Carcinoma: A Prospective Observational Study on Oral Cancer Patients at AIIMS Rishikesh

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/07/026335
Enrollment
116
Registered
2020-07-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

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

Interventions

None listed

Sponsors

Kinjal Shankar Majumdar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically proven squamous cell carcinoma of oral cavity. 2. ECOG PS: 0 – 2. 3. Resectable stage I – IV tumours.

Exclusion criteria

Exclusion criteria: 1. Patients with recurrent or residual head and neck cancers or second primaries treated with radiation with or without chemotherapy 2. Presence of synchronous malignancies. 3. Previous history of radiotherapy and/or chemotherapy for any other malignancy. 4. Patients with severe medical illness that preclude full participation in the study.

Design outcomes

Primary

MeasureTime frame
A subset of differentially expressed tumor immune infiltarates in tumor-core and tumor-stroma predict 1-year locoregional recurrence and distant metastasis.Timepoint: At the time of surgery, 3 months, 6 months, 9 months and 12 months—

Secondary

MeasureTime frame
A validated IHC panel to be used as a prognostic biomarker in oral squamous cell carcinoma.Timepoint: IEC approval, training of manpower: April 2020 - June 2020. Accrual: July 2020 - February 2021. Follow up, data analysis: March 2021 - February 2022.—

Countries

India

Contacts

Public ContactKinjal Shankar Majumdar

All India Institute of Medical Sciences Rishikesh

rajkumar.sonc@aiimsrishikesh.edu.in9940155250

Outcome results

None listed

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