Health Condition 1: R978- Other abnormal tumor markers
Conditions
Interventions
Intervention1: OncoVeryx: Early Detection of cancer by using 0.5 mL Serum on day 0
Control Intervention1: Nil: Nil
Sponsors
MS Clinfinite Solutions
PredOmix Technologies Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects who voluntarily participate in this study by signing their Informed Consent Form (ICF) in the local language prior to any study-mandated procedure. 2. Males or females aged = 18 years at time of signing the ICF. 3. Group 1: i. Subjects who are diagnosed with or suspected to have any cancer type. ii. Subjects must be treatment naive [i.e., should not have history of any chemotherapy, immunotherapy, radiotherapy etc.,].
Exclusion criteria
Exclusion criteria: 1. Currently participating in another investigational study. 2. Female subjects who are pregnant 3. Subjects with either high-grade dysplasia, autoimmune disease, or chronic kidney disease. 4. Subjects has a condition that, in the opinion of the investigator, would preclude participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Precision or accuracy of PredOmix OncoVeryx© in predicting the presence of cancer metabolites (= 90%) and the tissue of origin (75%) in all known samples collected in cancer population (Group 1). Precision or accuracy of PredOmix OncoVeryx© in predicting the presence of cancer metabolites (= 90%) and the tissue of origin (75%) in all known samples collected in healthy, non-cancerous population (Group 2).Timepoint: Screening Day 07 | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of PredOmix OncoVeryx© to observe accuracy in all unknown samples collected and to predict the accurate outcomes (Group 2).Timepoint: Screening Day 07 | — |
Countries
India
Contacts
Public ContactVikrant Tripathi
North East Cancer Hospital and Research Institute
Outcome results
None listed