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NCT03488862 · ClinicalTrials.gov registry record
Pilot Evaluation of a Microfluidic Assay to Detect Minimal Residual Disease and Predict Relapse in AML Patients
A clinical trial, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- 34
- Enrollment target
NCT03488862: Completed study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT03488862 is a clinical trial that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 34 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03488862 has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- 34 participants
- Enrollment target
Study Summary
Purpose: The purpose of this trial is to investigate whether a microfluidics assay can detect trace amounts of residual leukemia and predict relapse in acute myeloid leukemia (AML) patients in remission who have undergone allogeneic stem cell transplantation (SCT) or Induction and Consolidation Chemotherapy (ICC) at the North Carolina Cancer Hospital (NCCH). Procedures (methods): A total of 40 eligible subjects will be treated per standard of care with either SCT or induction and consolidation chemotherapy (ICC) based on the appropriate AML treatment paradigm for their disease. Peripheral blood (10 ml) for microfluidic chip analysis and possible Immune Monitoring Core Facility analysis will be collected along with routine lab draws prior to SCT. Patients in remission after SCT or those with confirmed remission by bone marrow biopsy after induction chemotherapy will be followed for 1 year; and peripheral blood (20 ml) will be collected to assess MRD by standard methods or by microfluidic chip analysis on a monthly basis. In addition, bone marrow biopsies will be performed at the end of consolidation (typically 5 months from remission), and at 1-year post remission in non-transplant patients. In transplanted patients, bone marrow biopsies will be collected at + 30 days, + 90 days, +180 days, and +360 days after SCT.
Primary Outcome
The number of detected AML cells will be recorded for each obtained blood sample. An indicator of relapse is when the number of AML cells exceeds the threshold pre-specified before the study. The goal is to evaluate the sensitivity and specificity of the device against clinically confirmed relapse.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2020-10-28 |
What the finished NCT03488862 record still lists
NCT03488862 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 34 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03488862 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03488862 about?
NCT03488862 is a clinical study titled "Pilot Evaluation of a Microfluidic Assay to Detect Minimal Residual Disease and Predict Relapse in AML Patients". Purpose: The purpose of this trial is to investigate whether a microfluidics assay can detect trace amounts of residual leukemia and predict relapse in acute myeloid leukemia (AML) patients in remission who have undergone allogeneic stem cell transplantation (SCT) or Induction and Consolidation Chem...
What is the current status of trial NCT03488862?
This trial is currently completed. The enrollment target is 34 participants. The study started on 2018-03-01. Estimated completion is 2020-10-28.
Who is sponsoring clinical trial NCT03488862?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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