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A single-arm, multicenter clinical application study of human erythrocyte lifespan measurement by CO breath test in differential diagnosis of polycythemia

A single-arm, multicenter clinical application study of human erythrocyte lifespan measurement by CO breath test in differential diagnosis of polycythemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016180
Enrollment
Unknown
Registered
2018-05-17
Start date
2018-06-08
Completion date
Unknown
Last updated
2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erythrocytosis

Interventions

Gold Standard:Lack of GS or RS, such as the 51Cr marker method, etc.

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 15 to 85 years old (The median age at diagnosis of polycythemia vera is about 60 years old, and the incidence of this disease gradually increases with age. The most patients are over 60-80 years old with polycythemia vera; 2. More than two times a week, male red blood cell count > 6*10^12/L and hemoglobin concentration>165 g/L or female red blood cell count > 5.5*10^12/L and hemoglobin concentration>160 g/L; The?subject have definite cause of disease and sign the informed consent. 3. Etiological diagnosis is carried out according to the latest international standards: (1) Polycythemia Vera GroupAbnormal bone marrow examination, JAK2 gene mutation positive, low or significantly reduced EPO levels; (2) None Polycythemia Vera GroupIncluding secondary polycythemia and relative polycythemia: 1) Secondary polycythemia in obstructive sleep disorder?Sleep apnea confirmed by sleep monitoring, high or significantly higher EPO, decreased saturation of arterial blood oxygen (SAO2); 2) Secondary polycythemia in the increase of tumor or renal derived EPO secretionAbnormal liver and kidney function examination,related focus comfirmed?by imaging or pathological findings; 3) Relative polycythemia caused by adrenocortical insufficiency; The total cortisol base value is less than 3 mu g/dl,normal EPO level.

Exclusion criteria

Exclusion criteria: 1. Severe cardiopulmonary disease; 2. In use of hydroxyurea and other myelosuppressive drugs for treatement; 3. Smoking within 24 hours before test; 4. Severe passive smoking or in other environment seriously polluted by high concentration of CO within 24 hours before test; 5. Incapable of self completing exhalation; 6. In process of other clinical trials involving drugs or medical devices within 3 months before test; 7. The researchers think it is not appropriate for him or her to take part in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Erythrocyte lifespan;

Secondary

MeasureTime frame
Erythropoietin (EPO);Reticulocyte percentage(Ret%);

Countries

China

Contacts

Public ContactZonghong Shao

Department of Hematology, Tianjin Medical University General Hospital

shaozonghong@sina.com+86 13802036467

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026