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

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).

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 Overview

• Status: Completed
• Conditions: Cystic Fibrosis; Pulmonary Failure
• Intervention / Treatment: Other: Lung transplantation

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France, 69495
    • Service de médecine interne Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	10 years

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): October 30, 2017

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): November 30, 2017

Study Record Updates

• Last Update Posted (Actual): November 30, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: MUCO TRANSPLAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No