Breath test could replace needles for blood disorder diagnosis
NCT ID NCT03008642
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a non-invasive breathing technique (CO-rebreathing) to measure red blood cell mass in people with polycythemia, a condition with too many red blood cells. The goal was to see if it works as well as the standard radioactive test. Sixty adults took part, and the results could lead to a simpler, safer diagnostic option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CO-rebreathing technique
- What this could lead to
- If successful, this could provide a faster, non-invasive alternative to the standard isotopic test for diagnosing polycythemia, making diagnosis easier in more clinics.
- What could go wrong
- This is a small, completed study with only 60 participants, so results may not apply to everyone. The CO-rebreathing method may not be as accurate as the standard test.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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60 people
The number who actually took part.
- Started
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Apr 2019
- Finished
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May 2020
- 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.
- Ages
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18 to 80 years
- 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: 1. Adult patient 2. Informed consent obtained 3. Requirement of an isotopic red cell mass determination: a - Hematocrit between 52 and 60% (men) or 48 and 56% (women) with no argument for a PV (JAK2V617F negative, EPO level normal/high). b - Patients with a JAK2V617F positive MPN and a hematocrit level between 46 and 50% (women) or 48 and 52% for men. 4. No recent vascular event (\<6 mois) 5. No unstable coronaropathy 6. Non smoking since 24 hours. 7. ECOG \<2 8. Negativity of pregnancy test/effective contraception for childbearing age women, 9. Health insurance Exclusion Criteria: 1. Recent venous event \<1 months, cerebral stroke \< 6 mois) 2. Evolutive cardiopathy (\< 6 months) 3. Chronic Respiratory failure 4. Smokers with no withdrawal in the last 24 hours before CO-Rebreathing 5. Basal HbCO\>7% the day of CO-Rebreathing 6. Pregnant or breast feeding women 7. Patient enable to give an informed consent 8. Inclusion in an interventional clinical trial in the last three months. 9. Any contraindication to lung function testing
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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.
Contacts and locations
Locations
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CHU Amiens Picardie
Amiens, Picardie, 80054, France
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