Health Condition 1: C069- Malignant neoplasm of mouth, unspecified
Conditions
Interventions
Control Intervention1: Nil: Nil
Sponsors
Genoscope Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Group A: 1. Male or Female patients with age of eighteen (18) and above. 2. Patients without and with history of smoking, tobacco, alcohol, systemic disease on conventional oral examination, visible oral lesions on conventional oral examination and with good oral hygiene. Group B: 1. Male or Female patients with age of eighteen (18) and above. 2. Gender: Male and Female 3. Neo-adjuvant/ Adjuvant chemotherapy cases: Subjects who are prescribed to either take Neo-adjuvant/ Adjuvant chemotherapy at the time of diagnosis or latest after 1 cycle of chemotherapy 4. New cases: Subjects with aggressive malignancy and required to take adjuvant therapy should be enrolled at the time of diagnosis. 5. Relapse/ Recurrent cases at the time of diagnosis: Subjects who have previously undergone neoadjuvant or adjuvant chemotherapy and have relapse/recurrent OSCC. The saliva sample will be collected at the time of diagnosis of the recurrent malignancy, in confirmed relapse cases even if that means without prior chemo treatments 6. Patients who have undergone neo/adjuvant chemotherapy and immunotherapy and not shown signs of cancer in 5 years after diagnosis will be included as they are considered as internal controls to assess the efficacy of the test. 7. Smokeless and smoking tobacco Habituated and Nonhabituated patients head and neck cancer cases 8. Subsites: Buccal mucosa, retromolar trigone, alveolus, gingivobuccal sulcus, floor of mouth and tongue subsites.
Exclusion criteria
Exclusion criteria: Group A: 1. Paediatric patients 2. HIV/HBsAg/ HCV/Covid-19 positive patients 3. Patients with inability to understand the project or give consent 4. Severe cases with inability to give at-least 500ul of saliva 5. Pregnant or breastfeeding women. 6. Patients with undergoing active radiation or immunotherapy 7. Patients who have participated in another investigational clinical study within thirty (30) days before screening. 8. Inflammation, Cut or fissures in the oral cavity 9. Significant medical history, immune-compromised and patients with COVID19 illness at present. 10. Subjects with any other clinically significant unstable medical condition, life-threatening disease, which in the opinion of the Investigator would interfere with the study results. 11. Dementia or significantly altered mental status that would limit the ability to obtain informed consent and compliance with the requirements of this protocol. 12. Any acute or chronic medical, psychiatric condition, with any genetic or autoimmune disorders or laboratory abnormality in patients and controls that could increase the risk associated with trial participation or could interfere with interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry in the trial. 13. Inability/lack of willingness to comply with visits, treatment plans, protocol assessments or laboratory tests. Group B: 1. Paediatric patients 2. HIV/HBsAg/ HCV/Covid-19 positive patients 3. Patients with inability to understand the project or give consent 4. Severe cases with inability to give at-least 500ul of saliva 5. Pregnant or breastfeeding women. 6. Patients with active cycles of chemotherapy (more than 2 cycles) or currently undergoing active radiation or immunotherapy 7. Patients who have participated in another investigational clinical study within thirty (30) days before screening. 8. Inflammation, Cut or fissures in the oral cavity which was not a preview of Oral Cancer. 9. Patients with a history of cancer other than for selected group 10. Significant medical history, immune-compromised and patients with COVID19 illness at present. 11. Subjects with any other clinically significant unstable medical condition, life-threatening disease, which in the opinion of the Investigator would interfere with the study results. 12. Dementia or significantly altered mental status that would limit the ability to obtain informed consent and compliance with the requirements of this protocol. 13. Any acute or chronic medical, psychiatric condition, with any genetic or autoimmune disorders or laboratory abnormality in patients and controls that could increase the risk associated with trial participation or could interfere with interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry in the trial. 14. Inability/lack of willingness to comply with visits, treatment plans, protocol assessments or laboratory tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the sensitivity of the four-marker panel SALISCOPE companion assay in predicting chemotherapeutic refractoriness in oral squamous cell carcinoma patients using risk prediction scores in comparison to Histopathology Evaluation and RECIST GuidelinesTimepoint: 625 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the specificity and overall accuracy of the four-marker panel SALISCOPE companion assay in predicting chemotherapeutic refractoriness in oral squamous cell carcinoma patients using risk prediction scores in comparison to Histopathology Evaluation and RECIST Guidelines 2. To assess the sensitivity of the four-marker panel SALISCOPE companion assay in predicting relapse in oral squamous cell carcinoma patients using risk prediction scores in comparison to Histopathology Evaluation and RECIST Guidelines 3. To assess the specificity and accuracy of the four-marker panel SALISCOPE companion assay in predicting relapse in oral squamous cell carcinoma patients using risk prediction scores 4. To assess the sensitivity of the four-marker panel SALISCOPE companion assay in predicting immunotherapy efficacy in oral squamous cell carcinoma patients using risk prediction scores.Timepoint: 625 Days;5. To assess the sensitivity, specificity and accuracy of the four-marker panel SALISCOPE companion assay in predicting immunotherapy efficacy in oral squamous cell carcinoma patients using risk prediction scores in comparison to Histopathology Evaluation and RECIST Guidelines 6. To assess the sensitivity, specificity and accuracy of the four-marker panel SALISCOPE companion assay in predicting immunotherapy efficacy in oral squamous cell carcinoma patients using risk prediction scores in comparison to Histopathology Evaluation and RECIST Guidelines 7. To generate and validate the algorithm on correlative risk prediction scores based on SALISCOPE Companion Diagnostic Assay results and clinical outcomes in predicting the disease progression, aggressiveness and immunotherapeutic response for the oral squamous cell cancer treatment 8. To assess the ease of use and clinical adoption of the software in decision makingTimepoint: 625 Days | — |
Countries
India
Contacts
Public ContactDr Ashwini Kumar
HCG Aastha Cancer Centre
Outcome results
None listed