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| ID | Type | Description | Link |
|---|---|---|---|
| U54HL127672 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Rare Diseases Clinical Research Network | NETWORK |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The aim of this study is to conduct survey-based assessments for the safety of air travel in patients with pulmonary Langerhans cell histiocytosis (PLCH). The study will enroll patients through the clinic network at Rare Lung Disease Consortium (RLDC) and through the Histiocytosis Association website. Patients will have access to the questionnaire via REDCap (an online data management system) and each patient will be provided with a link to complete the survey. The investigators plan on enrolling approximately 200 patients with PLCH for the purpose of this study. Secondary aims of this study include further characterization of the clinical aspects of disease and to establish a contact registry for these patients, in order to facilitate future studies.
The study will enroll participants through the clinic network at the Rare Lung Disease Consortium (RLDC) and through the Histiocytosis Association websites. Participants will have access to the questionnaire via REDCap (an online data management system) and each participant will be provided a link to complete the survey. In case of lack of internet access or inability to complete the online questionnaire, a paper survey will be mailed out with a pre-paid envelope to return the survey.
Primary Study Objective(s):
To define the risk of pneumothorax associated with air travel in patients with PLCH.
Secondary Study Objective(s):
To establish a contact registry for patients with PLCH to facilitate future trials To assess the rate of pneumothorax recurrence in patients with PLCH To assess the efficacy of pleurodesis in preventing recurrent pneumothoraces among patients with PLCH
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With PLCH Who Experienced Spontaneous Pneumothorax During or Within 24 Hours Following Air Travel | The investigators will measure the number of pneumothoraces that occur either during air travel, or within 24 hours of air travel among patients with pulmonary Langerhans cell histiocytosis. The incidence of air travel related pneumothorax will be calculated by dividing the number of pneumothoraces to the total number of flights undertaken by the entire cohort. | During air travel or within 24 hours following air travel |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Pulmonary Langerhans Cell Histiocytosis Who Experienced a Spontaneous Pneumothorax | The investigators will catalogue the number of spontaneous pneumothoraces experienced by patients with pulmonary Langerhans cell histiocytosis. | 2 years and 6 months |
| Number of Patients With Pulmonary Langerhans Cell Histiocytosis Who Experienced Recurrent Pneumothorax |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with Pulmonary Langerhans Cell Histiocytosis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45267-0564 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31563637 | Derived | Singla A, Kopras EJ, Gupta N. Spontaneous pneumothorax and air travel in Pulmonary Langerhans cell histiocytosis: A patient survey. Respir Investig. 2019 Nov;57(6):582-589. doi: 10.1016/j.resinv.2019.07.004. Epub 2019 Sep 26. |
| Label | URL |
|---|---|
| Link to completing the online study questionnaire | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort | Self-reported PLCH participants who completed an online survey. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort | Self-reported PLCH participants who completed an online survey. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With PLCH Who Experienced Spontaneous Pneumothorax During or Within 24 Hours Following Air Travel | The investigators will measure the number of pneumothoraces that occur either during air travel, or within 24 hours of air travel among patients with pulmonary Langerhans cell histiocytosis. The incidence of air travel related pneumothorax will be calculated by dividing the number of pneumothoraces to the total number of flights undertaken by the entire cohort. | Posted | Count of Participants | Participants | During air travel or within 24 hours following air travel |
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This was a cross-sectional survey, filled out online. The only risk was potential data breech. All-cause mortality, serious adverse events and other adverse events were not collected as part of this study.
This was a cross-sectional survey, filled out online. The only risk was potential data breech. All-cause mortality, serious adverse events and other adverse events were not collected as part of this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort | Self-reported PLCH participants who completed an online survey. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Kopras | University of Cincinnati | 513-558-4831 | koprasej@uc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2017 | Dec 8, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 23, 2017 | Dec 8, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006646 | Histiocytosis, Langerhans-Cell |
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D015614 | Histiocytosis |
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The investigators will measure the number of participants who experience a recurrent spontaneous pneumothorax. |
| 2 years and 6 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Counts |
|---|
| Participants |
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| Secondary | Number of Patients With Pulmonary Langerhans Cell Histiocytosis Who Experienced a Spontaneous Pneumothorax | The investigators will catalogue the number of spontaneous pneumothoraces experienced by patients with pulmonary Langerhans cell histiocytosis. | Posted | Count of Participants | Participants | 2 years and 6 months |
|
|
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| Secondary | Number of Patients With Pulmonary Langerhans Cell Histiocytosis Who Experienced Recurrent Pneumothorax | The investigators will measure the number of participants who experience a recurrent spontaneous pneumothorax. | Posted | Count of Participants | Participants | 2 years and 6 months |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010995 | Pleural Diseases |