Clinical trial NCT03138395: iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML
Official title: Predicting Disease Relapse by Monitoring Circulating Cancer DNA After Chemotherapy in Patients With MDS and AML
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Leukemia
Myelodysplastic Syndromes
AML
MDS
Keywords: acute myeloid leukemia
myelodysplastic syndrome
relapse
PCR
droplet digital
polymerase chain reaction
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AML and MDS patients who have already consented or prospectively consent to participate on iCare for Cancer (IRB 201500073) and the Malignant Hematology Bank (IRB 201501063) to participate in this study.

Brief summary: 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.

Detailed description: The greatest challenge in cancer is relapsed disease. Despite best available therapies, approximately 20% of acute myeloid leukemia (AML) patients and 80% of myelodysplastic syndrome (MDS) patients die of relapsed disease. Minimal residual disease (MRD) is the main predictor of refractory disease following chemotherapy. In AML and MDS patients, mutant allele frequency (MAF) associates with future occurrence of relapse. Current oncology practice relies on painful bone marrow biopsies and light microscopy to monitor disease progression, remission, and relapse. Because of the bias in disease sampling and low sensitivity testing, there is an urgent need for a higher sensitivity test to monitor the tumor burden in these patients. The Investigator developed a rapid and ultrahigh sensitivity method to detect cancer-associated mutant alleles. This study will use our droplet digital PCR (ddPCR) method to quantify and track peripheral blood plasma 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. Results from this project will generate a non-invasive means to monitor cancer response and progression months before current clinical methods, and provide an opportunity to intervene before the patient relapses. Furthermore, establishing a quantitative method to measure cancer burden will empower clinical researchers to measure biological activity in phase II and III clinical trials of new therapeutic agents.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Myeloid Mutations
timeFrame: 1 year
Secondary outcomes:
measure: Number of Myeloid Mutations in circulating DNA tumor (ctDNA) mutations
timeFrame: 1 year
measure: Mutant Allele Frequency (MAF) Ratio
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Leylah Drusbosky, PhD
role: PRINCIPAL_INVESTIGATOR
References: