Lung Graft DysfunctionCAssIOPéNCT06113224
Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion
A study testing Blood collection T0 and Blood collection 6 months in people with Lung Graft Dysfunction, run by Assistance Publique Hopitaux De Marseille.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Lung Graft Dysfunction
- What is being tested?
- Blood collection T0 and Blood collection 6 months
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient receiving a cryopreserved pulmonary valve homograft
- Patient aged 14 or over
- Signature of consent by adult patients/parents/guardians and assent by children
- Patientsreceiving a cardiac surgery with extracorporeal circulation and without lung homograft
Who cannot join
- Emergency surgery patient
- Pregnant women or childbirth within the last 6 months
- Transfusion during the surgery or within the last 6 months
- Patient with DSAs detected before the surgery
- Patient with anti-HLA antibodies (non-DSAs) detected before the surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion (CAssIOPé)
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.
Read the detailed description
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.
- Conditions
- Lung Graft Dysfunction
- Being tested
- Blood collection T0, Blood collection 6 months
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collection T0Procedure or surgery
2 blood samples will be taken in addition to the pre-operative check-up.
Blood collection 6 monthsProcedure or surgery
1 blood sample will be taken 6 months after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control patients | Active comparator | Patients with an indication for cardiac surgery with extracorporeal circulation but without homograft Receives: Procedure: Blood collection T0; Procedure: Blood collection 6 months |
| Lung homograft patients | Experimental | patients requiring lung homograft implantation Receives: Procedure: Blood collection T0; Procedure: Blood collection 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of DSA at 6 months
Luminex® detection of DSA at 6 months after lung homograft implantation
Measured: 6 months
Secondary outcomes (3)
DSA Quantification
DSA will be quantified in patients who developed DSA 6 months after lung homograft implantation
Measured: 6 months
antibody anti-HDLA (non DSA) detection
Detection or non-detection of non-DSA anti-HLA antibodies will be assessed by Mean Fluorescence Intensity.
Measured: 6 months
Early degeneration of the homograft
The early degeneration of the homograft will be defined by the occurrence of at least one of the following criteria:
- Need to replace lung homograft
- Need for dilatation during catheterization of lung homografts
- Maximum gradient across the lung homograft ≥ 30mmhg on echography at 6 months
- Pulmonary insufficiency ≥ moderate on echography at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Graft DysfunctionStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113224
- Sponsor's protocol ID
- RCAPHM22_0448
- Acronym
- CAssIOPé
- Status last verified
- Oct 2023
- First submitted
- 27 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion (CAssIOPé)
- ClinicalTrials.gov ID
- NCT06113224
- Acronym / sponsor ID
- CAssIOPé / RCAPHM22_0448
- Conditions
- Lung Graft Dysfunction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control patients | Active comparator | Procedure: Blood collection T0, Procedure: Blood collection 6 monthsPatients with an indication for cardiac surgery with extracorporeal circulation but without homograft |
| Lung homograft patients | Experimental | Procedure: Blood collection T0, Procedure: Blood collection 6 monthspatients requiring lung homograft implantation |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient receiving a cryopreserved pulmonary valve homograft
- Patient aged 14 or over
- Signature of consent by adult patients/parents/guardians and assent by children
- Patientsreceiving a cardiac surgery with extracorporeal circulation and without lung homograft
Key exclusion criteria (5 listed)
- Emergency surgery patient
- Pregnant women or childbirth within the last 6 months
- Transfusion during the surgery or within the last 6 months
- Patient with DSAs detected before the surgery
- Patient with anti-HLA antibodies (non-DSAs) detected before the surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collection T02 blood samples will be taken in addition to the pre-operative check-up. | Procedure or surgery | Control patients, Lung homograft patients |
| Blood collection 6 months1 blood sample will be taken 6 months after surgery. | Procedure or surgery | Control patients, Lung homograft patients |
Primary outcome
Detection of DSA at 6 months
Time frame: 6 months
Luminex® detection of DSA at 6 months after lung homograft implantation
3 secondary outcomes
DSA Quantification
Time frame: 6 months
antibody anti-HDLA (non DSA) detection
Time frame: 6 months
Early degeneration of the homograft
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
Related trials for Lung Graft Dysfunction
RecruitingObservational study
Evaluation of Patients With Immune Function Abnormalities
Chronic Granulomatous Disease (CGD), X-Linked Severe Combined Immune Deficiency (XSCID)
Not yet recruiting
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction
Not yet recruiting
Flow-Controlled vs. Pressure-Controlled Ventilation in CABG: Effects on Lung Aeration and Diaphragm Function
Coronary Artery Disease, Postoperative Pulmonary Complications
RecruitingPhase 1
A Clinical Study Evaluating the Pharmacokinetic Characteristics and Safety of AHB-137 Injection in Participants With Mild to Moderate Liver Dysfunction and Those With Normal Liver Function.
Chronic Hepatitis B
RecruitingObservational study
Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation
Primary Graft Dysfunction, Lung Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Blood collection T0 and Blood collection 6 months in people with Lung Graft Dysfunction, run by Assistance Publique Hopitaux De Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marien Lenois, PhD (+33 491386000, marien.lenoir@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of DSA at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.