Clinical trial NCT03548766: Using DNA-Typing and Erythrocyte Microparticle Analysis to Detect Blood Doping
Official title: Using DNA-Typing and Erythrocyte Microparticle Analysis to Detect Homologous/Autologous Blood Doping- a Transfusion Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Blood Disease
Blood Transfusion, Autologous
Blood Doping
Blood Transfusion, Homologous
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: World Anti-Doping Agency
name: Anti-Doping Lab Qatar
name: Sidra Medicine
name: Laboratorio Antidoping FMSI
First posted: 2018-06-07
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A total of 12 subjects will be recruited for participation in this study. 6 subjects will receive re-infusion of autologous blood, and 6 subjects (anemic patients) will receive a homologous transfusion.

Detailed description: Homologous blood transfusions (HBT) and autologous blood transfusions (ABT) are abused by athletes to illegally increase their hemoglobin mass and subsequently improve oxygen transport.

Anti-Doping labs use flow-cytometry to detect HBT in cheating athletes, but athletes avoid being tested positive by matching their blood for minor blood groups before transfusion. Recent publications suggest that DNA typing by Capillary Electrophoresis or RT-PCR might be an alternative way to detect this kind of doping in athletes. Unfortunately, no data exist on the clearance of DNA after transfusion of one bag of blood using this methodology.

For the detection of doping with ABT, there is no direct method available and only the biological passport, a longitudinal collection of hematological parameters can indicate doping. Recently RBC Microparticles (RBC-MPs) have been described as a potential biomarker for autologous transfusion. However, also for this methodology, no data on the clearance time of RBC-MPs are available.

Thus, in this World Anti-Doping Agency (WADA) approved and sponsored project. The investigators plan to perform a clinical trial in which six healthy subjects receive an ABT and six healthy subjects or patients a HBT. Blood samples will be collected before and at several time-points after transfusion. For the detection of HBT the samples will be analyzed by the official method (cytometry), and the two genotyping methods (STR and RT-PCR) to compare these different techniques and to see if DNA-typing can replace cytometry.

For the ABT the collected samples will be analyzed for RBC-MPs on a cytometer dedicated for Microparticles.

Eligibility criteria: Inclusion Criteria:

* both genders,
* age 20-50 years and
* preferably physically active but no elite athletes subjected to Anti-Doping testing.

Exclusion Criteria:

* vulnerable subjects
* not willing to participate
* not signing the ICF
* patients with end-organ failure

Primary outcomes:
measure: Donor DNA (# of loci with triplets or quadruplets):
timeFrame: 12 months
measure: Cellular Microparticles (10^3/uL):
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
affiliation: ADLQ
name: Sven Voss
role: STUDY_CHAIR
affiliation: Hamad Medical Corporation
name: Mohamed Yassin
role: PRINCIPAL_INVESTIGATOR
affiliation: Laboratorio Antidoping FMSI, Rome, Italy
name: Francesco Donati
role: PRINCIPAL_INVESTIGATOR
affiliation: ADLQ
name: Costas Georgakopoulos
role: PRINCIPAL_INVESTIGATOR
affiliation: ADLQ
name: Mohammed Alsayrafi
role: PRINCIPAL_INVESTIGATOR
affiliation: Sidra Medicine
name: Jean-Charles Grivel
role: PRINCIPAL_INVESTIGATOR
affiliation: Sidra Medicine
name: Christophe Raynaud
role: PRINCIPAL_INVESTIGATOR
References:
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