New test could spot leukemia relapse before it strikes
NCT ID NCT01311258
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study aims to develop special lab tests that can find tiny numbers of cancer cells left behind after treatment for acute myeloid leukemia (AML) or high-grade myelodysplastic syndrome (MDS). Researchers will follow 400 patients over time to see if these tests can predict which patients are more likely to have their cancer return. The goal is to improve monitoring and catch relapse early.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a blood test that warns doctors early if leukemia is coming back, allowing faster treatment.
- What could go wrong
- This is an observational study, not testing a new treatment. The tests may not reliably predict relapse in all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Aug 2007
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Hematology/oncology clinic
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Are being evaluated for the diagnosis and/or treatment of Acute Myelogenous Leukemia or High Grade myelodysplastic syndrome (defined as greater than 10 percent blasts on examination of the bone marrow aspirate). * Have not undergone prior cytotoxic therapy for acute myelogenous leukemia or High Grade myelodysplastic syndrome in the past 3 months other than hydroxyurea or Revlimid. * Have not previously received an allogeneic peripheral blood or bone marrow stem cell transplant for their disease. * Are able to sign an informed consent. Informed consent must be signed at the time of enrollment and prior to the collection of any specimens and/or clinical data (other than PHI needed to screen and identify patients, which will be promptly discarded in a secure fashion if patient is not enrolled on study) * Are at least 18 years of age. * Do not have any serious medical or psychiatric illness, other than that treated by this study which would limit the ability of the patient to receive therapy or give informed consent. * Have been informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: * Subjects who are less than 18 years of age. * Subjects with limited decision making capacity. * Subjects who have received prior cytotoxic therapy, other than hydroxyurea or Revlimid, for their disease within the past three months. * Patients with a diagnosis of chronic myelogenous leukemia in blast crisis, Acute Promyelocytic Leukemia, or Bi-lineage leukemia. * Subjects who have previously undergone an allogeneic peripheral blood stem cell transplant. * Have an active malignancy other than acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) at the time of evaluation or a prior history of treatment for a malignancy other than AML or MDS within the past 2 years.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Rochester Medical Center
RECRUITINGRochester, New York, 14642, United States
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Other studies related to the condition(s) this trial covers.
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- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
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- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?