Skip to main content
OpenTrials
Completed

NCT Number: NCT02439528

Genetics of the Combined Pulmonary Fibrosis and Emphysema Syndrome

The combined pulmonary fibrosis and emphysema syndrome (CPFE) individualized by our group in 2005 is characterized by an often severe dyspnea, almost exclusive male predominance, and often major, profound impairment of gas exchange contrasting with preserved lung volumes and absence of airflow obstruction, and a high risk of pre-capillary pulmonary hypertension responsible for increased mortality. Almost all patients are smokers or ex-smokers. There are some arguments in favor of genetic abnormalities in this syndrome of unknown etiology (other than smoking) including short telomeres and mutations in the telomerase complex genes. There are also emphysematous lesions, in patients with familial pulmonary fibrosis, with mutations in the SFTPC gene (surfactant protein C), and reported cases of CPFE syndrome with SFTPC mutation. No large genetic studies have been conducted to date in the CPFE syndrome. Our main hypothesis is that the proportion of subjects with short telomeres is higher among patients with CPFE syndrome than in subjects of similar age with idiopathic pulmonary fibrosis but without emphysema. It has previously been shown that mutations in the telomerase TERT or TERC genes are mostly found in people whose telomeres are abnormally short. The investigators propose to use that test to identify patients most likely carrying a mutation, and to seek, among them, the mutations in the TERT or TERC telomerase genes. The objective of the study is to compare the proportion of patients with short telomeres in the group of patients with CPFE syndrome to that of other patients (with idiopathic pulmonary fibrosis without emphysema, or with emphysema without fibrosis).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital pneumologique et cardiovasculaire Louis Pradel, HCL, Bron, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 80 years old.
  • Patient with Idiopathic Pulmonary Fibrosis Or
  • Patient with emphysema Or
  • Patient with combined pulmonary fibrosis and emphysema syndrome Or
  • Patient reporting no chronic lung disease

Exclusion criteria

  • Other causes of interstitial lung disease or context:
  • Connective
  • Pneumonia drug
  • Pneumoconiosis
  • Sarcoidosis
  • histiocytosis, lymphangioleiomyomatosis, etc.
  • Refusal to participate in the study or to sign the consent
  • Inability to give informed about the information
  • Woman breastfeeding or pregnant
  • No coverage for Social Security
  • Deprivation of Civil Rights

Treatment and study plan

Genetic analysis

Genetic

One part of these patients is already included in a cohort: for them the blood sample will be centralized and then analyzed.

The other part of these patients will be recruited during the study: for them intervention will be blood samples for further genetic analysis.

Primary outcomes

  1. Telomere length

    Time frame: At inclusion

    The primary endpoint is the percentage of patients with telomere length less than the 10th percentile of the age range for each type of patient

Secondary outcomes

  1. Mutation of the telomerase complex genes evaluated by gene sequencing.

    Time frame: At inclusion

    Frequency of the telomerase complex mutations measured by the percentage of patients having at least one mutation of the complex.

  2. Mutations in the gene encoding the SFTPC evaluated by gene sequencing

    Time frame: At inclusion

    Frequency of mutations in the gene encoding the SFTPC surfactant protein C measured by the percentage of patients having at least one mutation of the complex

  3. Patients characteristics evaluated by clinical examination

    Time frame: At inclusion

    Comparison of each type of patients with controls

  4. Genetic profile evaluated by gene sequencing.

    Time frame: At inclusion

    Description of the mutations found, relations with the phenotype

  5. Total mortality evaluated by phone call contact

    Time frame: 6 months

    6 months after inclusion, patients will be contacted to know their clinical status.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: GENES-SEF

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 8, 2015
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.