Clinical trial · Observational
iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML
Predicting Disease Relapse by Monitoring Circulating Cancer DNA After Chemotherapy in Patients With MDS and AML
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study design modified to collect specimens from a bank requiring a separate IRB-approved protocol.
Summary
Brief summary (as posted)
This study will use droplet digital PCR (ddPCR) method to quantify and track peripheral blood plasma mutant allele frequency (MAF) in MDS and AML patients before, during and after chemotherapy treatment. Quantification of MAF from fingersticks and saliva samples will also be performed to determine feasibility of obtaining adequate circulating tumor DNA (ctDNA) for ddPCR.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| MDS | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| droplet digital PCR | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Experimental: Specimen Collection
- description
- Collection of peripheral blood and bone marrow samples will occur during routine care procedures. Collection of finger stick and saliva specimens will occur on the same day as the peripheral blood and bone marrow procedure, or during routine clinical procedures.
- interventionNames
- Diagnostic Test: droplet digital PCR
Primary outcomes (1)
- measure
- Number of Myeloid Mutations
- timeFrame
- 1 year
- description
- To count the number of myeloid mutations with the use of a droplet digital PCR (ddPCR) method which will quantify and track peripheral blood plasma, finger stick blood sample, and saliva mutant allele frequency (MAF) in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) patients before, during and after chemotherapy treatment.
Secondary outcomes (2)
- measure
- Number of Myeloid Mutations in circulating DNA tumor (ctDNA) mutations
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical diagnosis of MDS or AML; * Have previously consented or prospectively consent to participate in iCare for Cancer (IRB201500073) and the Malignant Hematology Bank (IRB201501063); and * Must be 18 years of age or older. Exclusion Criteria: * Have not previously consented or prospectively consent to participate in iCare for Cancer (IRB201500073) and the Malignant Hematology Bank (IRB201501063); and * Must be 100 years of age or less.
References
Publications (0)
Data not yet available