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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)

Primary Purpose

Thalassemic Syndromes

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Free α-Hb pool analysis
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thalassemic Syndromes focused on measuring Alpha-Hemoglobin Stabilizing Protein, alpha-Hb pool, thalassemias, diagnostic method, biomarker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Henri Mondor Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Blood sample

Arm Description

A blood collection is carry out in the three populations of patients during the day of their enrolment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Correlation between the pool of free α-Hb and Hb value
Correlation between the pool of free α-Hb and Mean Corpuscular Hb
Correlation between the pool of free α-Hb and Mean Cell Volume
Correlation between the pool of free α-Hb and percent of reticulocytes
Correlation between the pool of free α-Hb and fetal Hb
Correlation between the pool of free α-Hb and erythrocyte enzymes

Full Information

First Posted
July 31, 2016
Last Updated
July 31, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Paris 12 Val de Marne University
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1. Study Identification

Unique Protocol Identification Number
NCT02855957
Brief Title
Evaluation of the Free α-hemoglobin Pool in the Red Blood Cells : Prognostic Marker and Severity Index in Thalassemic Syndromes
Acronym
ALPHAPOOL
Official Title
Evaluation of the Free α-hemoglobin Pool in the Red Blood Cells : Prognostic Marker and Severity Index in Thalassemic Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Paris 12 Val de Marne University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thalassemic Syndromes
Keywords
Alpha-Hemoglobin Stabilizing Protein, alpha-Hb pool, thalassemias, diagnostic method, biomarker

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood sample
Arm Type
Other
Arm Description
A blood collection is carry out in the three populations of patients during the day of their enrolment.
Intervention Type
Other
Intervention Name(s)
Free α-Hb pool analysis
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Correlation between the pool of free α-Hb and Hb value
Time Frame
Day 1
Title
Correlation between the pool of free α-Hb and Mean Corpuscular Hb
Time Frame
Day 1
Title
Correlation between the pool of free α-Hb and Mean Cell Volume
Time Frame
Day 1
Title
Correlation between the pool of free α-Hb and percent of reticulocytes
Time Frame
Day 1
Title
Correlation between the pool of free α-Hb and fetal Hb
Time Frame
Day 1
Title
Correlation between the pool of free α-Hb and erythrocyte enzymes
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Galacteros, MD PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21264907
Citation
Vasseur C, Pissard S, Domingues-Hamdi E, Marden MC, Galacteros F, Baudin-Creuza V. Evaluation of the free alpha-hemoglobin pool in red blood cells: a new test providing a scale of beta-thalassemia severity. Am J Hematol. 2011 Feb;86(2):199-202. doi: 10.1002/ajh.21918.
Results Reference
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Evaluation of the Free α-hemoglobin Pool in the Red Blood Cells : Prognostic Marker and Severity Index in Thalassemic Syndromes

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