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Non-respiratory Comorbidities Observed in Pulmonary French Transplant Patients With Cystic Fibrosis (MUCO TRANSPLAN)

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ClinicalTrials.gov Identifier: NCT03357913
Recruitment Status : Completed
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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. 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.


Condition or disease Intervention/treatment
Pulmonary Failure Cystic Fibrosis Other: Lung transplantation

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Non-respiratory Comorbidities Observed in Pulmonary French Transplant Patients With Cystic Fibrosis - Exploratory Study From the French Cohort on 2004-2014.
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: Lung transplantation
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




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Patients followed in Rhône Alpes but transplanted elsewhere in France will not be included.
  • Patient refusing to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357913


Locations
France
Service de médecine interne Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03357913     History of Changes
Other Study ID Numbers: MUCO TRANSPLAN
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases