CompletedNot Applicable

CO-Rebreathing in Comparison to Isotopic Red Cell Volume Determination in the Diagnosis of Primitive and Secondary Polycythemia

France60 participantsStarted 2019-04-01

Plain-language summary

The optimized CO-Rebreathing is an efficient method to evaluate the red cell mass and has been used in the vast majority of studies in sport medicine. However, this method has never been evaluated on a large scale in the diagnosis of primitive or secondary polycythemia. The standard procedure to evaluate the red cell mass is based on isotopic measurement using Cr51-labelled red cells, but its lack of availability in many centers highlights the need for a non-invasive and rapid alternative method. The purpose of this study is to evaluate and validate the CO-Rebreathing method in this set of indications.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adult patient
. Informed consent obtained
. Requirement of an isotopic red cell mass determination:
. No recent vascular event (\<6 mois)
. No unstable coronaropathy
. Non smoking since 24 hours.
. ECOG \<2
. Negativity of pregnancy test/effective contraception for childbearing age women,

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

equivalence of RCM determination by CO-Rebreathing in comparison to the traditional isotopic measurement in the diagnosis of polycythemia

Timeframe: 1 month

Trial details

NCT IDNCT03008642

SponsorCentre Hospitalier Universitaire, Amiens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-01

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