Health Condition 1: C000- Malignant neoplasm of external upper lip Health Condition 2: C001- Malignant neoplasm of external lower lip Health Condition 3: C002- Malignant neoplasm of external lip, unspecified Health Condition 4: C003- Malignant neoplasm of upper lip, inner aspect Health Condition 5: C004- Malignant neoplasm of lower lip, inner aspect Health Condition 6: C005- Malignant neoplasm of lip, unspecified, inner aspect Health Condition 7: C006- Malignant neoplasm of commissure of lip, un
Conditions
Interventions
Intervention1: Not Applicable: Not Applicable
Control Intervention1: Not Applicable: Not Applicable
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients must have recurrent or metastatic oral cancer at the time of diagnosis and must not have undergone any prior treatment. 2. Ability to follow study procedures, including regular follow-ups and assessments, with signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have already received palliative systemic chemotherapy for oral cancer will be excluded. 2. Severe allergies to drugs in the TMC-I regimen. 3. Significant cardiovascular issues like stroke, heart attack, or serious arrhythmias requiring medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Identification of response / resistance markers in TMC-I treated oral cancer patients using WES and RNA-sequencing and their correlation with treatment outcomes. 2.Validation of identified genomic alterations on a larger cohort of patient samples to confirm the results. Timepoint: For objective 1, 50 patient samples will be collected retrospectively for 6 months followed by data analysis and gene panel development. For objective 2, 198 patient samples will be collected prospectively for 1.5 years (6th to 18th month of the study), followed by data analysis and interpretation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Understanding disease biology and resistance mechanisms by longitudinal monitoring of the identified alterations over time using liquid biopsy (ctDNA) approach.Timepoint: For this objective, 50 patients from the earlier 198 patients will be selected prospectively and their samples collected every 3-4 months for 1.5 to 2 years, for sequencing using ctDNA approach, followed by data analysis and interpretation. | — |
Countries
India
Contacts
Public ContactDr Vanita Noronha
Tata Memorial Hospital
Outcome results
None listed