Purpose of this Study
This study does not test a new treatment. People will continue to receive their regular transplant care. The study looks at blood and DNA samples to learn if a blood test called AlloHeme can help doctors find signs that a disease may come back after a transplant.
For donors, the study lasts about two years. They will give a blood sample before the transplant and then provide blood samples and a cheek swab during follow up visits after the transplant. Researchers will compare the donor and recipient DNA samples to look for early signs that the disease might return.
For transplant recipients, participation is much shorter. They will provide one small blood sample for DNA testing during a single study visit that lasts about 30 minutes. After that sample is collected, their participation in the study is complete.
Who Can Participate?
Eligibility
People can join this study if they are adults who are scheduled to receive a stem cell transplant. It also includes family members who are donating stem cells for a patient in the FORWARD study. Participants must be willing to provide a blood sample and allow researchers to perform DNA testing. The goal is to help researchers learn more about how to detect early signs that certain blood diseases may return after a transplant.
Age Range
18-100
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes
What is Involved?
Description
The purpose of this study is to find out if a blood test called AlloHeme can help predict whether blood diseases called acute myeloid leukemia or myelodysplastic syndrome will come back after a stem cell transplant. Researchers will study blood samples and compare DNA from donors and patients over time. The goal is to see if this test can find early signs that the disease is returning so doctors may be able to help patients sooner in the future.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML/MDS Patients (FORWARD): A multicenter, prospective observational cohort study in US transplant centers
Principal Investigator
Nelson
Chao
Protocol Number
PRO00120574
NCT ID
NCT07607327
Enrollment Status
Pending Open to Enrollment