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A Biobank for Diaphragm Muscular Fiber (BOTAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02900300
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : April 18, 2019
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
The first aim of the study is to obtain from chirurgical micro biopsy myoblast in culture which will differentiate in Diaphragm fiber. Then these fibers will be submitted under mechanical stress condition similar to those imposed in vivo by mechanical ventilation to validate in human a model in vitro of diaphragm dysfunction induced by mechanical ventilation. Then the second part of the study will be to evaluate with this model, the efficiency of an antioxidant therapy.

Condition or disease
Diaphragm Dysfunction Mechanical Ventilation

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Constitution of a Biobank to Optimize in Vitro an Antioxydant Treatment for Diaphragm Dysfunction Induced by Mechanical Ventilation
Actual Study Start Date : October 2016
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : December 31, 2018

Primary Outcome Measures :
  1. Myoblast differentiation capacity [ Time Frame: 24 month ]
    Description: evaluation of ROS (reactive oxygen species) production by confocal microscopie of diaphragm fiber submitted in vitro by mechanical stress.

Secondary Outcome Measures :
  1. Myoblast proliferation capacity [ Time Frame: 24 month ]
    Description: Evaluation of diaphragm myoblast differenciation capacity in vitro under different concentration of antioxydant.

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient who benefeciat of a thoracotomy for local pulmonary resection in regard to a lung cancer.

Inclusion Criteria:

  • Patient who will undergo a surgery for a localised broncho-pulmonary tumor (stade 1A), and have stopped to smoke since more than 6 month and clinically stable.

Exclusion Criteria:

  • Patients with neuro-muscular disorder, heart desease, chronic obtructive pulmonary disease, metabolic disorder or infection.

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 identifier (NCT number): NCT02900300

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Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
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Study Director: Stefan MATECKI, PU-PH University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier Identifier: NCT02900300     History of Changes
Other Study ID Numbers: RECHMPL15_0389
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided