- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02855957
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
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-
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Creteil, France, 94010
- Henri Mondor Hospital
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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.
|
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.
Collaborators
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.
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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