Lung Transplant RecipientNCT03702257
DSA Intragraft in Lung Transplantation: Diagnostic and Prognostic Value in Antibody Mediated Rejection
A study testing bronchoscopy. in people with Lung Transplant Recipient and Donor Specific Antibodies, run by University Hospital, Strasbourg, France at 5 sites in France.
Trial summary
The diagnosis of AMR in lung transplant recipients is difficult and often comes too late, because of lack of standardized definition. The diagnosis is nowadays based on an expert multidisciplinary approach involving clinical, histopathological and immunological criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant Recipient, Donor Specific Antibodies, Antibody Mediated Rejection
- What is being tested?
- bronchoscopy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesFrance
- Study dates
- 23 Aug 2019to 22 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient older than 18 years
- Transplanted pulmonary or cardiopulmonary patient
- And developing circulating anti-HLA antibodies directed against the graft or "DSA" at a threshold > 1000 of MFI in the 30 days preceding the inclusion visit
- Affiliation to the French social security
- Patient able to understand the objectives and risks related to research and to give informed, dated and signed consent
Who cannot join
- Patient whose anti-HLA antibodies are not directed against the graft (no DSA)
- Contraindication to performing a bronchial fibroscopy with transbronchial biopsies
- Treatment with intravenous immunoglobulin (less than 1 month before inclusion) or Rituximab (less than 6 months before inclusion)
- Plasma exchanges (less than 3 months before inclusion)
- Risk of bleeding predictable (crushing disorder, impossibility of stopping the offending treatments)
- Impossibility of giving the subject informed information
Show all 9Show fewer
- Subject under the protection of justice Subject under guardianship or curatorship
- Pregnancy
- Breastfeeding
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 5 recruiting
- Not yet recruiting
Hôpital Marie Lannelongue
Le Plessis-Robinson, 92350
Jérôme LE PAVEC, +33 1 40 94 24 30, lepavec@gmail.com
- Recruiting
CHU Nord
Marseille, 13915
Martine REYNAUD GAUBERT, +33 1 40 25 82 37, martine.reynaud@ap-hm.fr
- Not yet recruiting
Hôpital Bichat
Paris, 75018
Olivier BRUGIERE, +33 1 40 25 82 37, olivier.brugiere@aphp.fr
- Recruiting
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Sandrine HIRSCHI, +33 3 69 55 11 78, sandrine.hirschi@chru-strasbourg.fr
Sandrine HIRSCHI
- Not yet recruiting
Hôpital Foch
Suresnes, 92151
Antoine ROUX, +33 1 46 25 37 31, a.roux@hopital-foch.org
About this study
Official title: Intérêt Diagnostique et Pronostique de la présence d'Anticorps spécifiques du Donneur Intra-greffon Dans le Rejet Humoral en Transplantation Pulmonaire
The diagnosis of AMR in lung transplant recipients is difficult and often comes too late, because of lack of standardized definition. The diagnosis is nowadays based on an expert multidisciplinary approach involving clinical, histopathological and immunological criteria.
Hypothesis: the presence of intragraft donor specific antibodies (gDSAs) could be used as a new diagnostic tool for AMR in lung transplant recipients Study Objectives: to evaluate, in lung transplant patients with circulating DSAs, the diagnostic value of gDSAs in AMR and to analyze its prognostic value on graft outcome.
- Being tested
- bronchoscopy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoscopy.Procedure or surgery
gDSAs are studied on cryopreserved biopsies obtained during bronchoscopy. The technique is the one described by Visentin J.
| Study group | Role | What they receive |
|---|---|---|
| Bronchial fibroscopy | Other | Bronchial fibroscopy with trans-bronchial biopsies Receives: Procedure: bronchoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of AMR
Sensitivity and specificity of the presence of gDSA for the diagnosis of AMR in lung transplant recipients with circulating DSA, as established by an expert pathologist panel and in accordance with recent international recommendations
Measured: 2 years
Secondary outcomes (1)
Comparaison in gDSA+ vs gDSAs- patients
Incidence of graft loss
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start23 Aug 2019
- Primary completion22 Feb 2026 (estimated)
- Study completion22 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant RecipientStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702257
- Sponsor's protocol ID
- 7039
- Status last verified
- Feb 2022
- First submitted
- 8 Oct 2018
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intérêt Diagnostique et Pronostique de la présence d'Anticorps spécifiques du Donneur Intra-greffon Dans le Rejet Humoral en Transplantation Pulmonaire
- ClinicalTrials.gov ID
- NCT03702257
- Acronym / sponsor ID
- 7039
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 22 Feb 2026 (estimated)
- Study completion
- 22 Feb 2026 (estimated)
- First posted
- 11 Oct 2018 (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.
The diagnosis of AMR in lung transplant recipients is difficult and often comes too late, because of lack of standardized definition. The diagnosis is nowadays based on an expert multidisciplinary approach involving clinical, histopathological and immunological criteria.
Hypothesis: the presence of intragraft donor specific antibodies (gDSAs) could be used as a new diagnostic tool for AMR in lung transplant recipients Study Objectives: to evaluate, in lung transplant patients with circulating DSAs, the diagnostic value of gDSAs in AMR and to analyze its prognostic value on graft outcome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchial fibroscopy | Other | Procedure: bronchoscopy.Bronchial fibroscopy with trans-bronchial biopsies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient older than 18 years
- Transplanted pulmonary or cardiopulmonary patient
- And developing circulating anti-HLA antibodies directed against the graft or "DSA" at a threshold > 1000 of MFI in the 30 days preceding the inclusion visit
- Affiliation to the French social security
- Patient able to understand the objectives and risks related to research and to give informed, dated and signed consent
Key exclusion criteria (9 listed)
- Patient whose anti-HLA antibodies are not directed against the graft (no DSA)
- Contraindication to performing a bronchial fibroscopy with transbronchial biopsies
- Treatment with intravenous immunoglobulin (less than 1 month before inclusion) or Rituximab (less than 6 months before inclusion)
- Plasma exchanges (less than 3 months before inclusion)
- Risk of bleeding predictable (crushing disorder, impossibility of stopping the offending treatments)
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 |
|---|---|---|
| bronchoscopy.gDSAs are studied on cryopreserved biopsies obtained during bronchoscopy. The technique is the one described by Visentin J. | Procedure or surgery | Bronchial fibroscopy |
Primary outcome
Diagnosis of AMR
Time frame: 2 years
Sensitivity and specificity of the presence of gDSA for the diagnosis of AMR in lung transplant recipients with circulating DSA, as established by an expert pathologist panel and in accordance with recent international recommendations
1 secondary outcome
Comparaison in gDSA+ vs gDSAs- patients
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bronchoscopy. in people with Lung Transplant Recipient and Donor Specific Antibodies, run by University Hospital, Strasbourg, France at 5 sites in France.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandrine HIRSCHI (+33 3 69 55 11 78, sandrine.hirschi@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of AMR (time frame: 2 years). 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 14 Feb 2022.