Acute LeukemiaiCare3NCT03138395
iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML
An observational study of Acute Leukemia and Myelodysplastic Syndromes, run by University of Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Leukemia, Myelodysplastic Syndromes, AML
- What is being tested?
- droplet digital PCR
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2017to 15 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Predicting Disease Relapse by Monitoring Circulating Cancer DNA After Chemotherapy in Patients With MDS and AML
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.
Read the 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.
- Conditions
- Acute Leukemia, Myelodysplastic Syndromes, AML, MDS
- Being tested
- droplet digital PCR
- Keywords
- acute myeloid leukemia, myelodysplastic syndrome, relapse, PCR, droplet digital, polymerase chain reaction
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
droplet digital PCRDiagnostic test
Also called ddPCR
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Specimen Collection | 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. Receives: Diagnostic Test: droplet digital PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Myeloid Mutations
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.
Measured: 1 year
Secondary outcomes (2)
Number of Myeloid Mutations in circulating DNA tumor (ctDNA) mutations
To count the number myeloid mutations in ctDNA through the collection of serial samples from AML and MDS patients to determine minimal residual disease (MRD) or relapse free survival.
Measured: 1 year
Mutant Allele Frequency (MAF) Ratio
To count the overall number of finger stick and saliva ctDNA MAF and compare it to the overall number of peripheral blood and bone marrow MAF.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start15 Sep 2017 (estimated)
- Primary completion15 Feb 2018 (estimated)
- Study completion15 Aug 2019 (estimated)
Why it stopped: Study design modified to collect specimens from a bank requiring a separate IRB-approved protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leylah Drusbosky, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138395
- Sponsor's protocol ID
- IRB201700351
- Other IDs
- iCare3, 15963
- Acronym
- iCare3
- Status last verified
- Aug 2017
- First submitted
- 25 Apr 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Disease Relapse by Monitoring Circulating Cancer DNA After Chemotherapy in Patients With MDS and AML
- ClinicalTrials.gov ID
- NCT03138395
- Acronym / sponsor ID
- iCare3 / IRB201700351
- Conditions
- Acute Leukemia, Myelodysplastic Syndromes, AML, MDS
- Keywords
- acute myeloid leukemia, myelodysplastic syndrome, relapse, PCR, droplet digital, polymerase chain reaction
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study design modified to collect specimens from a bank requiring a separate IRB-approved protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 15 Sep 2017 (estimated)
- Primary completion
- 15 Feb 2018 (estimated)
- Study completion
- 15 Aug 2019 (estimated)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Specimen Collection | – | Diagnostic Test: droplet digital PCRCollection 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| droplet digital PCRAlso: ddPCRThis 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. | Diagnostic test | Experimental: Specimen Collection |
Primary outcome
Number of Myeloid Mutations
Time frame: 1 year
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.
2 secondary outcomes
Number of Myeloid Mutations in circulating DNA tumor (ctDNA) mutations
Time frame: 1 year
Mutant Allele Frequency (MAF) Ratio
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leylah Drusbosky, PhD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukemia and Myelodysplastic Syndromes, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Myeloid Mutations (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017.