Lung Transplant RejectionDATACOLNCT04837339
Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation
A study testing Collection of biological samples in people with Lung Transplant Rejection and Lung Transplant Failure, run by Hopital Foch at 1 site in France.
Trial summary
Transplant results vary considerably from one organ to another. Lung transplantation has poorer long-term outcomes than other solid organ transplants, with a current median post-transplant survival of 6.0 years. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Lung Transplant Rejection, Lung Transplant Failure, Lung Transplant; Complications
- What is being tested?
- Collection of biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2022to Mar 2037
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men or women over 15 years of age
- Suffering from a lung condition requiring a transplant planned at Foch Hospital or being followed up at Foch Hospital following a lung transplant
- Have signed the informed consent form and for patients aged 15 to 18 years that the person(s) exercising parental authority has/have signed the informed consent.
- Be affiliated with a Health Insurance plan.
Who cannot join
- Pregnant, parturient and/or lactating woman
- Hemoglobin level less than or equal to 8g/dl
- Persons of full age who are subject to a legal protection measure or who are unable to express their consent
- Persons under the protection of justice
- Not being able to follow the study requirements for geographical, social or psychological reasons
- Patient refusal.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Transplant results vary considerably from one organ to another. Lung transplantation has poorer long-term outcomes than other solid organ transplants, with a current median post-transplant survival of 6.0 years. Allograft rejection remains the leading cause of morbidity and mortality in all organ groups and is the leading cause of death, accounting for more than 40% of deaths beyond the first year after lung transplantation.
Each dysfunctions impacts the fate of the graft and therefore the survival of the recipient. Their early and precise diagnosis is therefore a major issue. The identification of the pathophysiological mechanisms underlying these different subtypes of dysfunction (transcriptomics, polymorphism of target genes of the immune system or tissue repair, cell phenotyping) is an essential step. It can only be done on the basis of a collection of samples linked to a clinical database allowing to contextualize each sample.
- Conditions
- Lung Transplant Rejection, Lung Transplant Failure, Lung Transplant; Complications, Lung Transplant Failure and Rejection
- Being tested
- Collection of biological samples
- Keywords
- DATACOL
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of biological samplesOther
Blood sample, biopsies sample, hair sample.
| Study group | Role | What they receive |
|---|---|---|
| Patients with lung disease requiring transplantation or who have undergone lung transplantation | Other | There is no intervention to be administered. Receives: Other: Collection of biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate non-invasive markers of dysfunction to stratify the risk of rejection, present in the blood during the first year after transplantation (blood immunomarkers).
Correlation between blood biomarkers (cell free DNA, Donor Specific Antibodies characterization) and graft rejection.
Measured: 15 years
Secondary outcomes (5)
Evaluate relevant gene sets associated with high or low risk profiles of acute dysfunction and rejection (intragraft expression).
Correlation of biomarkers (graft) with the functionality of the allograft
Measured: 15 years
Stratify lung transplant recipients using non-invasive biomarkers and a gene expression profile for risk of allograft loss based on first year post-transplant data
Assessment of the risk of graft loss based on biomarker variations in repeated measurements.
Measured: 15 years
Identify biomarkers and gene sets associated with response to immunosuppressive treatments of rejection
Correlation between gene expression in lung transplants and response to treatment of rejection
Measured: 15 years
Evaluate the costs associated with the use of invasive and non-invasive strategies to define the risk of allograft rejection.
Costs incurred to define the risk of allograft rejection
Measured: 15 years
Assessing patient acceptability and well-being using invasive and non-invasive biomarkers
Variation in patient well-being with the use of a non-invasive strategy to define the risk of allograft rejection
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start17 Mar 2022
- Primary completionMar 2037 (estimated)
- Study completionMar 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant RejectionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837339
- Sponsor's protocol ID
- 2019_0015
- Acronym
- DATACOL
- Status last verified
- Aug 2022
- First submitted
- 2 Nov 2020
- Last updated
- 3 Aug 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 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation
- ClinicalTrials.gov ID
- NCT04837339
- Acronym / sponsor ID
- DATACOL / 2019_0015
- Conditions
- Lung Transplant Rejection, Lung Transplant Failure, Lung Transplant; Complications, Lung Transplant Failure and Rejection
- Keywords
- DATACOL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- Mar 2037 (estimated)
- Study completion
- Mar 2037 (estimated)
- First posted
- 8 Apr 2021 (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.
Transplant results vary considerably from one organ to another. Lung transplantation has poorer long-term outcomes than other solid organ transplants, with a current median post-transplant survival of 6.0 years. Allograft rejection remains the leading cause of morbidity and mortality in all organ groups and is the leading cause of death, accounting for more than 40% of deaths beyond the first year after lung transplantation.
Each dysfunctions impacts the fate of the graft and therefore the survival of the recipient. Their early and precise diagnosis is therefore a major issue. The identification of the pathophysiological mechanisms underlying these different subtypes of dysfunction (transcriptomics, polymorphism of target genes of the immune system or tissue repair, cell phenotyping) is an essential step. It can only be done on the basis of a collection of samples linked to a clinical database allowing to contextualize each sample.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with lung disease requiring transplantation or who have undergone lung transplantation | Other | Other: Collection of biological samplesThere is no intervention to be administered. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women over 15 years of age
- Suffering from a lung condition requiring a transplant planned at Foch Hospital or being followed up at Foch Hospital following a lung transplant
- Have signed the informed consent form and for patients aged 15 to 18 years that the person(s) exercising parental authority has/have signed the informed consent.
- Be affiliated with a Health Insurance plan.
Key exclusion criteria (6 listed)
- Pregnant, parturient and/or lactating woman
- Hemoglobin level less than or equal to 8g/dl
- Persons of full age who are subject to a legal protection measure or who are unable to express their consent
- Persons under the protection of justice
- Not being able to follow the study requirements for geographical, social or psychological reasons
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 |
|---|---|---|
| Collection of biological samplesBlood sample, biopsies sample, hair sample. | Other | Patients with lung disease requiring transplantation or who have undergone lung transplantation |
Primary outcome
Evaluate non-invasive markers of dysfunction to stratify the risk of rejection, present in the blood during the first year after transplantation (blood immunomarkers).
Time frame: 15 years
Correlation between blood biomarkers (cell free DNA, Donor Specific Antibodies characterization) and graft rejection.
5 secondary outcomes
Evaluate relevant gene sets associated with high or low risk profiles of acute dysfunction and rejection (intragraft expression).
Time frame: 15 years
Stratify lung transplant recipients using non-invasive biomarkers and a gene expression profile for risk of allograft loss based on first year post-transplant data
Time frame: 15 years
Identify biomarkers and gene sets associated with response to immunosuppressive treatments of rejection
Time frame: 15 years
Evaluate the costs associated with the use of invasive and non-invasive strategies to define the risk of allograft rejection.
Time frame: 15 years
Assessing patient acceptability and well-being using invasive and non-invasive biomarkers
Time frame: 15 years
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 3 Aug 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Lung Transplant Rejection
RecruitingPhase 1
Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies
Lung Transplantation
RecruitingPhase 3
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Lung Transplant Rejection
RecruitingPhase 1
A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation
Antibody Mediated Rejection of Lung Transplant
RecruitingPhase 2
Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
Lung Transplant
RecruitingObservational study
Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
Lung Transplant; Complications, Lung Transplant; Infection or Inflammation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of biological samples in people with Lung Transplant Rejection and Lung Transplant Failure, run by Hopital Foch at 1 site 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 Antoine ROUX, Dr (0146252635 ext. +33, a.roux@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate non-invasive markers of dysfunction to stratify the risk of rejection, present in the blood during the first year after transplantation (blood immunomarkers). (time frame: 15 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 3 Aug 2022.