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Evaluation of the Free α-hemoglobin Pool in the Red Blood Cells : Prognostic Marker and Severity Index in Thalassemic Syndromes (ALPHAPOOL)

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ClinicalTrials.gov Identifier: NCT02855957
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : August 4, 2016
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Paris 12 Val de Marne University
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
Our project aims to assess and validate an innovative prognostic and diagnostic test in order to i) define a severity index of the β-thalassemia according to the free α-Hb pool for a better management of the patient; ii) differentiate the α-thalassemia and β-thalassemia and iii) follow the evolution of this pool in response to treatment of patients. In the future, this prognostic test based on the measurement of free α-Hb pool may be suitable for routine laboratory practice. To carry out this project, cohort of 85 thalassemic patients and a group of 50 healthy volunteers have been recruited.

Condition or disease Intervention/treatment Phase
Thalassemic Syndromes Other: Free α-Hb pool analysis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Free α-hemoglobin Pool in the Red Blood Cells : Prognostic Marker and Severity Index in Thalassemic Syndromes
Study Start Date : June 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : June 2016

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Arms and Interventions
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Arm Intervention/treatment
Blood sample
A blood collection is carry out in the three populations of patients during the day of their enrolment.
 Other: Free α-Hb pool analysis


Outcome Measures
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Primary Outcome Measures :
  1. Correlation between the pool of free α-Hb and genotype α and β -globin of the patient and if necessary with the genotype AHSP gene [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Correlation between the pool of free α-Hb and Hb value [ Time Frame: Day 1 ]
  2. Correlation between the pool of free α-Hb and Mean Corpuscular Hb [ Time Frame: Day 1 ]
  3. Correlation between the pool of free α-Hb and Mean Cell Volume [ Time Frame: Day 1 ]
  4. Correlation between the pool of free α-Hb and percent of reticulocytes [ Time Frame: Day 1 ]
  5. Correlation between the pool of free α-Hb and fetal Hb [ Time Frame: Day 1 ]
  6. Correlation between the pool of free α-Hb and erythrocyte enzymes [ Time Frame: Day 1 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria Patient

  • Age ≥ 18 years
  • Written informed consent
  • Affiliation to social security
  • Known Hb Phenotypes
  • Biological phenotype corresponding to a classical picture of thalassemia

Healthy volunteers

  • Age ≥ 18 years
  • Written informed consent
  • Affiliation to social security

Exclusion Criteria Patient

  • Transfusion for less than 3 months
  • Chronic active viral disease: hepatitis B, C, HIV
  • Ongoing infections or known inflammatory diseases
  • Hyper or Hypothyroidism known or subject treated by Levothyrox
  • Active pathology or tumor remission for less than 5 years
  • Oral corticosteroid
  • Hemoglobinopathy other than thalassemia for patients
  • Treatment by Hydroxyurea for more than 3 months
  • Treatment by stimulating agent erythropoiesis for longer than 3 months

Healthy volunteers

  • Transfusion for less than 3 months
  • Chronic active viral disease: hepatitis B, C, HIV
  • Ongoing infections or known inflammatory diseases
  • Hyper or Hypothyroidism known or subject treated by Levothyrox
  • Active pathology or tumor remission for less than 5 years
  • Oral corticosteroid
  • Genetically related to person with hemoglobinopathy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855957


Locations
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France
Henri Mondor Hospital
Creteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Paris 12 Val de Marne University
Investigators
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Principal Investigator: Frédéric Galacteros, MD PhD Assistance Publique - Hôpitaux de Paris
More Information
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Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02855957    
Other Study ID Numbers: P120205
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: July 2016
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Alpha-Hemoglobin Stabilizing Protein
alpha-Hb pool
thalassemias
diagnostic method
biomarker
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes