Evaluation of the Free α-hemoglobin Pool in the Red Blood... | NCT02855957

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

NCT02855957

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Aug 4, 2016Estimated

Enrollment

135Actual

Phase

Not Applicable

Conditions

Thalassemic Syndromes

Interventions

Free α-Hb pool analysis

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jul 2015Actual

Completion Date

Jun 2016Actual

First Submitted Date

Jul 31, 2016

First Submission Date that Met QC Criteria

Jul 31, 2016

First Posted Date

Aug 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2016

Last Update Posted Date

Aug 4, 2016Estimated

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV
Paris 12 Val de Marne University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

135Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Free α-Hb pool analysis	Other		Blood sample

Outcomes Module

Primary Outcomes

Measure	Description	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		Day 1

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Frédéric Galacteros, MD PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Henri Mondor Hospital		Créteil		94010	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21264907	Background	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.

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases