Health Condition 1: C959- Leukemia, unspecified
Conditions
Interventions
Intervention1: Diagnostic method of Dried blood spot test method: Leukemia Transcript determination will be done for study duration of 4 years
Control Intervention1: Conventional method for dioagnosti
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Untreated new acute lymphoblastic leukemia and Acute myeloid leukemia , Aged 1 month to 60 years irrespective of Gender, enrolled at study sites , diagnosed on flowcytometry using WHO criteria 2022. 2. Patients/guardians who have given informed consent given for participation in the study 3.Leukemia Patients with no history of chronic disease/MDS/ Chemotherapy/ Immunological deficient states (Routine protocol)
Exclusion criteria
Exclusion criteria: 1. Lymphoproliferative disorder other than leukemia (Lymphoma, CMPN-AL, Secondary leukemia, MDS-AL) 2. Patients who are partially treated/referred after treatment initiation 3. Patients who are having biohazard exposures like HIV, Hbs Ag,� HCV 4. Patients/guardians who are not willing to give consent for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of DBS for transcript determinationTimepoint: Calculation of sensitivitya nd specificity will be done at baseline for diagnosis of leukemia transcript, for all samples with both conventional and DBS method | — |
Secondary
| Measure | Time frame |
|---|---|
| PPV & NPV will be calculated for both methods at the end of Trial durationTimepoint: One at the end of trial at the time of diagnosis once only.No longitudinal follow up data willbe collected | — |
Countries
India
Contacts
Public ContactDr Aroonima Misra
ICMR-NICHDR,
Outcome results
None listed