Health Condition 1: null- Neoadjuvant Head & Neck cancer or Triple Negative breast cancer
Conditions
Interventions
Control Intervention1: Compare the CANScript outcome vs Clinical Outcome: Evaluate the sensitivity and specificity of CANScript platform by correlating the CANScript outcome vs clinical outcome in an
Sponsors
Mitra Biotech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with Ca-H&N requiring neo-adjuvant therapy or refractory/ relapsed triple negative breast cancer , aged 18-75 are eligible for the ACCEPT trial. 2. Patients from whom at least 100-200 mm3 non-necrotic tumor can be obtained by biopsy or surgery. 3.ECOG Performance Status of 0 - 1 4. Triple NEgative BReast cancer patients must be tested negative for ER, PR & HER2 receptor expression
Exclusion criteria
Exclusion criteria: Any other concurrent disease or illness, which in the judgment of the investigator would make the subject inappropriate for entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response to the anti-cancer drug administered by the investigator will be assessed by PET/CT imaging. CANScript outcome will be available for comparison of predicted and actual responseTimepoint: Clinical response for each patient will be recorded post 2 months from the date of enrolment. The clinical outcomes will be compared with CANScript outcomes of respective patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Follow up phase for study of progression free survivalTimepoint: Up to 2 years from baseline visit or patient death whichever is early | — |
Countries
India
Contacts
Public ContactRagini C Iyer
Mitra Biotech Pvt. Ltd
Outcome results
None listed