Health Condition 1: C069- Malignant neoplasm of mouth, unspecified
Conditions
Interventions
Intervention1: Case group - Patients diagnosed with oral cancer or oral potentially malignant disorder: Patient with biopsy proven oral cancer
Biopsy proven or clinically diagnosed case of oral poten
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: Case - control study (Phase 2): Case Group: Patient with biopsy proven oral cancer Biopsy proven or clinically diagnosed case of oral potentially malignant disorder (OPMD) Aged 18 years or above. Those with primary or recurrent malignant of oral cavity. Those who are willing to provide informed consent. Control group: A person above the age of 18 with no known case of cancer and are visiting the hospital during the study period. They could be attendants/care givers of the patient. Those with medical conditions not related to oral cancer/ OPMD, tobacco or alcohol. Those who are willing to provide informed consent Phase 3: Model feasibility study: A person who is above 18 years of age. Willing to provide informed consent and information about their tobacco/alcohol habits
Exclusion criteria
Exclusion criteria: Case - control study (Phase 2): Case group: Patients who are critically ill, need for emergency management or admitted to the intensive care units. Currently displaying COVID-19 related symptoms, namely a fever, cough and/or difficulty breathing or having been positively tested as infected with COVID-19 in the past 14 days. Patients who are not willing disclose details about their tobacco/ alcohol habits. Control group: Patients with confirmed diagnosis of oral cancer or oral potentially malignant disorder or any kind of oral lesion. Those with cancers other than oral cancer. Currently displaying COVID-19 related symptoms, namely a fever, cough and/or difficulty breathing or having been positively tested as infected with COVID-19 in the past 14 days. Patients who are not willing disclose details about their tobacco/ alcohol habits. Phase 3: Model feasibility study: Those who are not willing to disclose details about their tobacco/alcohol habits. Those not willing to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Risk factors and their strength of association with oral cancer through a systematic review and meta- analysis (Phase 1). Sensitivity, specificity, and predictability of OraCLE in risk stratification of oral cancer (Phase 2). The degree of exposure to tobacco/alcohol among cases and control (Phase 2). Feasibility and ease of applicability of OraCLE (Phase 3). To arrive at a scientifically validated, feasible, user-friendly, and generalizable pre-screening tool for oral cancer. Timepoint: Phase 1: Apr 2024 - Apr 2025 Phase 2: Apr 2025 - Apr 2026 Phase 3: Apr 2026 - Apr 2027 | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility and ease of applicability of OraCLE (Phase 3).Timepoint: Phase 3: Apr 2026 - Apr 2027 | — |
Countries
India
Contacts
Public ContactAswathi G
Kasturba Medical College, MAHE
Outcome results
None listed