NCT02855957

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
Last Updated

August 4, 2016

Status Verified

July 1, 2016

Enrollment Period

2.1 years

First QC Date

July 31, 2016

Last Update Submit

July 31, 2016

Conditions

Thalassemic Syndromes

Keywords

Alpha-Hemoglobin Stabilizing Proteinalpha-Hb poolthalassemiasdiagnostic methodbiomarker

Outcome Measures

Primary Outcomes (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

    Day 1

Secondary Outcomes (6)

  • Correlation between the pool of free α-Hb and Hb value

    Day 1

  • Correlation between the pool of free α-Hb and Mean Corpuscular Hb

    Day 1

  • Correlation between the pool of free α-Hb and Mean Cell Volume

    Day 1

  • Correlation between the pool of free α-Hb and percent of reticulocytes

    Day 1

  • Correlation between the pool of free α-Hb and fetal Hb

    Day 1

  • +1 more secondary outcomes

Study Arms (1)

Blood sample

OTHER

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

Other: Free α-Hb pool analysis

Interventions

Free α-Hb pool analysisOTHER
Blood sample

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

Location

Related Publications (1)

  • 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.

    PMID: 21264907BACKGROUND

MeSH Terms

Conditions

Thalassemia

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Frédéric Galacteros, MD PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2016

First Posted

August 4, 2016

Study Start

June 1, 2013

Primary Completion

July 1, 2015

Study Completion

June 1, 2016

Last Updated

August 4, 2016

Record last verified: 2016-07

Locations

FR(1)