- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03008642
CO-Rebreathing in Comparison to Isotopic Red Cell Volume Determination in the Diagnosis of Primitive and Secondary Polycythemia (Poly-CO)
CO-Rebreathing in Comparison to Isotopic Red Cell Volume Determination in the Diagnosis of Primitive and Secondary Polycythemia: a Multicentric Study. Co-Rebreathing for the Measurement of Total Red Cell Mass in Polycythemia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The definition of a true polycythemia is stricto sensu an increased red cell mass (RCM) above 125% of the expected value depending on the size and the weight of the patient. However, this measurement requires an isotopic labeling of red cells and is not available in most of the hospitals. Therefore, the diagnosis of polycythemia, and particularly Polycythemia Vera (PV) is based on routine red blood cells parameters, i.e. hemoglobin level and hematocrit. If these parameters are efficient in marked polycythemia, discrepancies have been observed in milder cases. Two situations where a RCM evaluation is particularly required can be described:
- In patients with a hematocrit level between 52 and 60% (men) or between 48 and 56% (women) in order to limit invasive investigations to patients with a confirmed polycythemia diagnosis
- In JAK2V617F positive myeloproliferative neoplasms (MPN) with hematocrit and hemoglobin levels under the PV cut-off in order to discriminate between masked PV and essential thrombocythemia CO-Rebreathing is a fast, non invasive alternative method for RCM evaluation. It is based on the high affinity of carbon monoxide (CO) for hemoglobin. The decrease in the HbCO percentage after CO inhalation is dependent on the total hemoglobin mass from which RCM can be obtained. The investigators propose a tri-centric study evaluating CO-Rebreathing as an alternative tool to measure RCM in the diagnosis of polycythemia in the two categories of patients described above.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Loïc GARCON, professor
- Phone Number: +33 322 087 056
- Email: garcon.loic@chu-amiens.fr
Study Contact Backup
- Name: Mohamed AIT AMER MEZIANE, Phd
- Phone Number: +33 322 088 384
- Email: aitamermeziane.mohamed@chu-amiens.fr
Study Locations
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Picardie
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Amiens, Picardie, France, 80054
- CHU Amiens Picardie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patient
- Informed consent obtained
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.
- 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,
- Health insurance
Exclusion Criteria:
- Recent venous event <1 months, cerebral stroke < 6 mois)
- Evolutive cardiopathy (< 6 months)
- Chronic Respiratory failure
- Smokers with no withdrawal in the last 24 hours before CO-Rebreathing
- Basal HbCO>7% the day of CO-Rebreathing
- Pregnant or breast feeding women
- Patient enable to give an informed consent
- Inclusion in an interventional clinical trial in the last three months.
- Any contraindication to lung function testing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CO-Rebreathing
The intervention consists in one red cell mass determination using the CO-Rebreathing technique at diagnosis of polycythemia, in addition to the regular tests performed in this indication, including RCM isotopic measurement.
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The intervention consists in one red cell mass determination using the CO-Rebreathing technique at diagnosis of polycythemia, in addition to the regular tests performed in this indication, including RCM isotopic measurement.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
equivalence of RCM determination by CO-Rebreathing in comparison to the traditional isotopic measurement in the diagnosis of polycythemia
Time Frame: 1 month
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The primary outcome is to prove the equivalence of RCM determination by CO-Rebreathing in comparison to the traditional isotopic measurement in the diagnosis of polycythemia.
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AE / SAE / EI
Time Frame: 1 month
|
Incidence, grade type according to NCI-CTCAE v4.0
|
1 month
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Cumulative incidence of thrombotic and hemorrhagic complications
Time Frame: 1 month
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Cumulative incidence of thrombotic and hemorrhagic complications List according to PT1 protocol.
|
1 month
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Deaths and causes
Time Frame: 1 month
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Deaths and causes
|
1 month
|
Analysis of the results of VGTCO and VGTi
Time Frame: 1 month
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Analysis of the results of VGTCO and VGTi as a function of hemoglobin and hematocrit
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1 month
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Collaborators and Investigators
Investigators
- Study Director: Loïc GARCON, professor, CHU Amiens-Picardie
- Principal Investigator: Lydia ROY, Doctor, CHU Henri Mondor, France
- Principal Investigator: Marjolaine GEORGES, Doctor, Centre Hospitalier Universitaire Dijon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2016_843_0032
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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