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Blood test may end painful bone marrow biopsies for MDS patients

NCT ID NCT07081087

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new blood test called PERIBLOOD-MDS that could diagnose a bone marrow disorder called MDS without needing a painful bone marrow biopsy. Researchers will compare results from the blood test with standard bone marrow exams in 1,500 adults with low blood counts. If the blood test proves accurate, it could make diagnosis much easier for patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PERIBLOOD-MDS diagnostic test
What this could lead to
If successful, this could replace painful bone marrow biopsies with a simple blood test for diagnosing MDS, making diagnosis faster and less invasive.
What could go wrong
This is an early-stage observational study, so the test may not prove accurate enough to replace bone marrow evaluation. Results are still being validated against standard methods.

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

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

Patients with cytopenia, who are referred to BM from the primary care clinic will be recruited to the study

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients aged 18 and up with suspected/confirmed MDS cases referred to BM evaluation either for diagnosis or risk assessment due to cytopenia 2. Platelets \< 150 × 10E9/L or 3. Absolute neutrophil count \< 1.8 × 10E9/L or 4. Hemoglobin (Hgb) \< 13 g/dL (males) and \< 12 g/dL (female) and 5. For both sexes, no evidence of Iron, folinic acid, or B12 deficiency Exclusion Criteria: 1. Women who are pregnant 2. Previous diagnosis of leukemia; AML, MPN, ALL, CLL, MGUS/MM or any other gammopathy 3. Lymphocytes \> 5000/ul 4. Patients who are on disease-related therapy are excluded, unless they are treated with Erythropoietin or Prednisone. See Appendix 2 for the list of excluded treatments. 5. Patients who have undergone a bone marrow transplant.

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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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • University of California San Diego

    RECRUITING

    San Diego, California, 92093, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33146, United States

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