Health Condition 1: C069- Malignant neoplasm of mouth, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Manipal Academy of Higher Education
Manipal Centre for Biotherapeutics Research
Manipal College of Dental Sciences
Manipal College of Pharmaceutical Sciences
Manipal Institute of Technology
Manipal School of Life Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. The person (irrespective of sex) should have been diagnosed with Oral Squamous Cell Carcinoma. 2. Pre-malignant stages (ulcers, early lesions) and early malignant stages (T1 and T2) cases will be considered for the study. 3. Patients with and without tobacco chewing, areca nut chewing, smoking, and alcohol consumption will be considered for the study.
Exclusion criteria
Exclusion criteria: 1. Individuals who are less than 18 years of age. 2. Patients diagnosed with late stages of OSCC (T3 and T4). 3. Patients characterized with highly malignant and metastatic OSCC with signs of excessive tumour outgrowth leading to the opening of mouth and trismus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is the analysis of microbiome composition, including bacterial diversity, dysbiosis patterns, and microbial taxa distribution. This will be assessed by comparing microbiome profiles among healthy individuals, individuals with premalignant conditions, and patients diagnosed with oral squamous cell carcinoma (OSCC).Timepoint: All outcomes will be assessed at a single time point, specifically at baseline, upon sample collection from cases and controls. Since this is a case-control study, no follow-up assessments will be conducted, and microbiome analysis will be based on retrospective comparison between study groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include comprehending the Dysbiosis Index to quantify microbial imbalance across the study groups and the identification of specific microbial taxa that may be associated with the progression from a non-cancerous state to OSCC.Timepoint: Single time point at baseline (upon sample collection) | — |
Countries
India
Contacts
Public ContactDr Bharath Prasad A S
Manipal School of Life Sciences
Outcome results
None listed