Pulmonary FailureMUCO TRANSPLANNCT03357913
Non-respiratory Comorbidities Observed in Pulmonary French Transplant Patients With Cystic Fibrosis
An observational study of Pulmonary Failure and Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Pulmonary transplantation is the reference treatment for chronic terminal respiratory failure in patients with cystic fibrosis. These are mainly bi-pulmonary transplants (cardiopulmonary transplants are exceptional). The annual number of pulmonary transplants in France for cystic fibrosis is about 90. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Failure, Cystic Fibrosis
- What is being tested?
- Lung transplantation
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2017to 30 Oct 2017
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population studied is the cohort of patients with cystic fibrosis who received a bipulmonary transplant between 2004 and 2014 in one of the two transplant centers in the Rhône-Alpes region.
Who may be able to join
- Patients with clinical diagnosis of cystic fibrosis
- Patients with Pulmonary transplant between 01/01/2004 and 31/12/2014
- Patients followed-up in one of the two pulmonary transplantation centers in the Rhône-Alpes region (Lyon, Grenoble)
Who cannot join
- Patients followed in Rhône Alpes but transplanted elsewhere in France will not be included.
- Patient refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Service de médecine interne Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69495
About this study
Official title: Non-respiratory Comorbidities Observed in Pulmonary French Transplant Patients With Cystic Fibrosis - Exploratory Study From the French Cohort on 2004-2014.
Pulmonary transplantation is the reference treatment for chronic terminal respiratory failure in patients with cystic fibrosis. These are mainly bi-pulmonary transplants (cardiopulmonary transplants are exceptional). The annual number of pulmonary transplants in France for cystic fibrosis is about 90. In 2013, the transplant involves a total of more than 600 patients with cystic fibrosis. The average age at the time of the transplant is 28.5 years (2013 data, French cystic fibrosis register), compared to 58 years for patients transplanted to all pathologies. Cystic fibrosis accounts for 25% of adult bi-pulmonary grafts. Pediatric transplants are currently very rare.
The median survival after pulmonary transplantation in cystic fibrosis is currently 8.5 years (and 10 years when considering patients surviving 3 months, ie excluding early mortality). Cystic fibrosis is the pathology associated with better survival after pulmonary transplantation given the young age of patients (28.5 years on average).
Read more
The non-respiratory comorbidities associated with transplantation, all underlying pathologies combined, and referenced in the Registry of the International Society for Heart and Lung Transplantation (ISHLT) are: hypertension, diabetes, renal insufficiency, Dyslipidemia, cancers. Their frequency increases with the survival time of transplanted patients. Cystic fibrosis is associated with non-respiratory comorbidities, the frequency of which increases with age - diabetes, osteoporosis, renal insufficiency, hepatopathy, neoplastic pathologies - and may become worse after transplantation.
The main objective is to estimate the incidence of non-respiratory co-morbidities after lung transplantation in the cohort of patients with cystic fibrosis grafted in the Rhône-Alpes region.
- Conditions
- Pulmonary Failure, Cystic Fibrosis
- Being tested
- Lung transplantation
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung transplantationOther
To estimate the incidence of non-respiratory co-morbidities after lung transplantation between 2004 and 2014 in the cohort of patients with cystic fibrosis grafted in the Rhône-Alpes region
| Study group | Role | What they receive |
|---|---|---|
| Co morbidities after lung transplantation in cystic fibrosis | The population studied is the cohort of cystic fibrosis patients who received a bipulmonary transplant between 2004 and 2014 in one of the two transplantation centers in the Rhône-Alpes region. Receives: Other: Lung transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of co-morbidities after lung transplantation
The incidence rate will be calculated at 1 year follow-up after lung transplantation.
The comorbidities studied will be:
- diabetes
- kidney failure
- high blood pressure
- hepatopathies
- undernutrition
- osteoporosis
- neoplasms, and in particular colon cancer
- gynecological complications (viral and neoplastic)
Measured: 1 year
Incidence of co-morbidities after lung transplantation
The incidence rate will be calculated at 2 years follow-up after lung transplantation.
The comorbidities studied will be:
- diabetes
- kidney failure
- high blood pressure
- hepatopathies
- undernutrition
- osteoporosis
- neoplasms, and in particular colon cancer
- gynecological complications (viral and neoplastic)
Measured: 2 years
Incidence of co-morbidities after lung transplantation
The incidence rate will be calculated at 5 years follow-up after lung transplantation.
The comorbidities studied will be:
- diabetes
- kidney failure
- high blood pressure
- hepatopathies
- undernutrition
- osteoporosis
- neoplasms, and in particular colon cancer
- gynecological complications (viral and neoplastic)
Measured: 5 years
Incidence of co-morbidities after lung transplantation
The incidence rate will be calculated at 10 years follow-up after lung transplantation.
The comorbidities studied will be:
- diabetes
- kidney failure
- high blood pressure
- hepatopathies
- undernutrition
- osteoporosis
- neoplasms, and in particular colon cancer
- gynecological complications (viral and neoplastic)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Jun 2017
- Primary completion1 Jun 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FailureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357913
- Sponsor's protocol ID
- MUCO TRANSPLAN
- Acronym
- MUCO TRANSPLAN
- Status last verified
- Nov 2017
- First submitted
- 20 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-respiratory Comorbidities Observed in Pulmonary French Transplant Patients With Cystic Fibrosis - Exploratory Study From the French Cohort on 2004-2014.
- ClinicalTrials.gov ID
- NCT03357913
- Acronym / sponsor ID
- MUCO TRANSPLAN / MUCO TRANSPLAN
- Conditions
- Pulmonary Failure, Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 30 Nov 2017 (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.
Pulmonary transplantation is the reference treatment for chronic terminal respiratory failure in patients with cystic fibrosis. These are mainly bi-pulmonary transplants (cardiopulmonary transplants are exceptional). The annual number of pulmonary transplants in France for cystic fibrosis is about 90. In 2013, the transplant involves a total of more than 600 patients with cystic fibrosis. The average age at the time of the transplant is 28.5 years (2013 data, French cystic fibrosis register), compared to 58 years for patients transplanted to all pathologies. Cystic fibrosis accounts for 25% of adult bi-pulmonary grafts. Pediatric transplants are currently very rare.
The median survival after pulmonary transplantation in cystic fibrosis is currently 8.5 years (and 10 years when considering patients surviving 3 months, ie excluding early mortality). Cystic fibrosis is the pathology associated with better survival after pulmonary transplantation given the young age of patients (28.5 years on average).
The non-respiratory comorbidities associated with transplantation, all underlying pathologies combined, and referenced in the Registry of the International Society for Heart and Lung Transplantation (ISHLT) are: hypertension, diabetes, renal insufficiency, Dyslipidemia, cancers. Their frequency increases with the survival time of transplanted patients. Cystic fibrosis is associated with non-respiratory comorbidities, the frequency of which increases with age - diabetes, osteoporosis, renal insufficiency, hepatopathy, neoplastic pathologies - and may become worse after transplantation.
The main objective is to estimate the incidence of non-respiratory co-morbidities after lung transplantation in the cohort of patients with cystic fibrosis grafted in the Rhône-Alpes region.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Co morbidities after lung transplantation in cystic fibrosis | – | Other: Lung transplantationThe population studied is the cohort of cystic fibrosis patients who received a bipulmonary transplant between 2004 and 2014 in one of the two transplantation centers in the Rhône-Alpes region. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population studied is the cohort of patients with cystic fibrosis who received a bipulmonary transplant between 2004 and 2014 in one of the two transplant centers in the Rhône-Alpes region.
Key inclusion criteria (3 listed)
- Patients with clinical diagnosis of cystic fibrosis
- Patients with Pulmonary transplant between 01/01/2004 and 31/12/2014
- Patients followed-up in one of the two pulmonary transplantation centers in the Rhône-Alpes region (Lyon, Grenoble)
Key exclusion criteria (2 listed)
- Patients followed in Rhône Alpes but transplanted elsewhere in France will not be included.
- Patient refusing to participate in the study
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 |
|---|---|---|
| Lung transplantationTo estimate the incidence of non-respiratory co-morbidities after lung transplantation between 2004 and 2014 in the cohort of patients with cystic fibrosis grafted in the Rhône-Alpes region | Other | Co morbidities after lung transplantation in cystic fibrosis |
Primary outcome
Incidence of co-morbidities after lung transplantation
Time frame: 1 year
The incidence rate will be calculated at 1 year follow-up after lung transplantation. The comorbidities studied will be: * diabetes * kidney failure * high blood pressure * hepatopathies * undernutrition * osteoporosis * neoplasms, and in particular colon cancer * gynecological complications (viral and neoplastic)
Incidence of co-morbidities after lung transplantation
Time frame: 2 years
The incidence rate will be calculated at 2 years follow-up after lung transplantation. The comorbidities studied will be: * diabetes * kidney failure * high blood pressure * hepatopathies * undernutrition * osteoporosis * neoplasms, and in particular colon cancer * gynecological complications (viral and neoplastic)
Incidence of co-morbidities after lung transplantation
Time frame: 5 years
The incidence rate will be calculated at 5 years follow-up after lung transplantation. The comorbidities studied will be: * diabetes * kidney failure * high blood pressure * hepatopathies * undernutrition * osteoporosis * neoplasms, and in particular colon cancer * gynecological complications (viral and neoplastic)
Incidence of co-morbidities after lung transplantation
Time frame: 10 years
The incidence rate will be calculated at 10 years follow-up after lung transplantation. The comorbidities studied will be: * diabetes * kidney failure * high blood pressure * hepatopathies * undernutrition * osteoporosis * neoplasms, and in particular colon cancer * gynecological complications (viral and neoplastic)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Failure
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Failure and Cystic Fibrosis, run by Hospices Civils de Lyon 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 30 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of co-morbidities after lung transplantation (time frame: 1 year). The study lists 4 primary outcomes in all. 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 30 Nov 2017.