Blood collection T0
Procedure2 blood samples will be taken in addition to the pre-operative check-up.
NCT Number: NCT06113224
This is a prospective, monocentric, observational cohort study whose main objective is to describe the number and rate of patients who developed DSAs (Donor Specific Antibody) at 6 months post-surgery with implantation of a cryopreserved lung homograft.
Trial opening soon.
Get Notified14 year and older
All sexes
Interventional
Not applicable
Lung homograft is used in a large number of complex malformations. It is accepted that homografts may induce immune reactions in the recipient, but no immunological studies have been carried out to characterize the recipient's immune reactions to the homograft and their potential impact on valve function. In this project, the authors propose to study the immunizing character of cryopreserved lung homografts by identifying the appearance of antibodies directed against the HLA, DSA (Donor Specific Antibodies) molecules of the graft (lung homograft) at 1 month and 6 months after its surgical implantation.The primary objective will be analyzed by describing the rate of patients who developed DSA at 6 months post-surgery with implantation of a cryopreserved lung homograft.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for control patients:
Inclusion criteria
for patients with lung homograft :
Exclusion criteria
for both group
2 blood samples will be taken in addition to the pre-operative check-up.
1 blood sample will be taken 6 months after surgery.
Time frame: 6 months
Luminex® detection of DSA at 6 months after lung homograft implantation
Time frame: 6 months
DSA will be quantified in patients who developed DSA 6 months after lung homograft implantation
Time frame: 6 months
Detection or non-detection of non-DSA anti-HLA antibodies will be assessed by Mean Fluorescence Intensity.
Time frame: 6 months
The early degeneration of the homograft will be defined by the occurrence of at least one of the following criteria:
Contact information is provided by the study sponsor or research team.
Clement PIERRE, PhD
CONTACT
Marien Lenois, PhD
CONTACT
Assistance Publique Hopitaux De Marseille
Other
Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion (CAssIOPé)
Acronym: CAssIOPé
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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