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NCT04920188 · ClinicalTrials.gov registry record
Development and Application of a Novel Digital Array PCR for Acute Myeloid Leukemia (AML)
A clinical trial, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Terminated
- Registry status
- 10
- Enrollment target
NCT04920188: Clinical Trial study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT04920188 is a clinical trial that was terminated before completion, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04920188 was terminated before completion, sponsored by UNC Lineberger Comprehensive Cancer Center.
- TERMINATED
- Registry status
- 10 participants
- Enrollment target
Study Summary
Purpose: The purpose of this trial is to investigate whether a digital array 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) at the North Carolina Cancer Hospital (NCCH). Participants: Adult patients (18 years of age or older) with diagnosed AML who are going to undergo stem cell transplant (SCT). Procedures (methods): A total of 10 eligible subjects will be treated per standard of care with SCT. Peripheral blood and bone marrow aspirate (10 mL each) for digital array assay analysis will be collected along with routine lab draws and bone marrow biopsy procedures prior to SCT. Beginning 1 month after SCT peripheral blood (10 ml) will be collected to assess MRD by digital array assay analysis on a monthly basis for up to 6 months. In addition, bone marrow aspirate will be collected at approximately Month 3 and 6 following SCT for assay analysis. Patient medical records will be reviewed 6 and 12 months after completing their last MRD follow up assessment to confirm survival status, remission status, and gather information related to relapse.
Primary Outcome
Signal intensity above negative control at mutation sites
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-05-28 |
| Est. Completion | 2024-05-25 |
Why NCT04920188 stopped before completion
NCT04920188 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04920188 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04920188 about?
NCT04920188 is a clinical study titled "Development and Application of a Novel Digital Array PCR for Acute Myeloid Leukemia (AML)". Purpose: The purpose of this trial is to investigate whether a digital array 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) at the North Carolina Cancer Hospit...
What is the current status of trial NCT04920188?
This trial is currently terminated. The enrollment target is 10 participants. The study started on 2021-05-28. Estimated completion is 2024-05-25.
Who is sponsoring clinical trial NCT04920188?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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