iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML

NCT03138395 | Withdrawn DMC

• 3 other identifiers: IRB201700351iCare315963
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Leukemia; Myelodysplastic Syndromes; AML; MDS

Keywords

acute myeloid leukemia; myelodysplastic syndrome; relapse; PCR; droplet digital; polymerase chain reaction

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (2)

• Number of Myeloid Mutations in circulating DNA tumor (ctDNA) mutations

  1 year

• Mutant Allele Frequency (MAF) Ratio

  1 year

Study Arms (1)

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.

Diagnostic Test: droplet digital PCR

Interventions

droplet digital PCR DIAGNOSTIC_TEST

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.

Also known as: ddPCR

Experimental: Specimen Collection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Biospecimen

Retention: SAMPLES WITH DNA

* venipuncture peripheral blood * bone marrow * finger stick peripheral blood * saliva

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Recurrence

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leylah Drusbosky, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 3, 2017
• Study Start: September 15, 2017
• Primary Completion: February 15, 2018
• Study Completion: August 15, 2019
• Last Updated: August 31, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share