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

July 31, 2016 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94010
        • Henri Mondor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between the pool of free α-Hb and Hb value
Time Frame: Day 1
Day 1
Correlation between the pool of free α-Hb and Mean Corpuscular Hb
Time Frame: Day 1
Day 1
Correlation between the pool of free α-Hb and Mean Cell Volume
Time Frame: Day 1
Day 1
Correlation between the pool of free α-Hb and percent of reticulocytes
Time Frame: Day 1
Day 1
Correlation between the pool of free α-Hb and fetal Hb
Time Frame: Day 1
Day 1
Correlation between the pool of free α-Hb and erythrocyte enzymes
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Paris 12 Val de Marne University

Investigators

  • Principal Investigator: Frédéric Galacteros, MD PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

July 31, 2016

First Submitted That Met QC Criteria

July 31, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

July 31, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P120205

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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