Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Creation of a Biospecimen Repository From Patients With Interstitial Lung Diseases (ILD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03478826
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Eva M. Carmona Porquera, Mayo Clinic

Brief Summary:
To develop a repository of blood samples from patients with ILD to support future studies into the development of such biomarkers. Patients with pneumonia and healthy patients will also be recruited as a control group.

Condition or disease Intervention/treatment
Interstitial Lung Disease Other: ILD Other: Healthy Other: Pneumonia

Detailed Description:
The proposed biospecimen repository would be derived from patients diagnosed with ILD. This is to include 500 patients in the repository, with each patient contributing one blood sample. Patients with pneumonia and healthy patients will also be recruited as a control group.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Creation of a Biospecimen Repository From Patients With Interstitial Lung Diseases (ILD)
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ILD
250 patients (male and females >18 years of age) with the diagnosis of fibrotic DILD (IPF (n=100), fibrotic NSIP (n=50), chronic hypersensitivity pneumonia (n=20), sarcoidosis(n=50), progressive rheumatoid lung disease (n=10) and scleroderma lung disease (n=20), 10 patients with other fibrosing disease (fibrosing mediastinitis), and 50 patients with lymphangioleiomyomatosis.
Other: ILD
100 cc of blood collected from a total of 250 ILD patients. This includes IPF (n=100), fibrotic NSIP (n=50), chronic hypersensitivity pneumonia (n=20), sarcoidosis(n=50), progressive rheumatoid lung disease (n=10) and scleroderma lung disease (n=20)), 10 patients with other fibrosing disease (fibrosing mediastinitis), and 50 patients with lymphangioleiomyomatosis

Healthy
100 healthy participants as a control group.
Other: Healthy
100 cc of blood collected from a total of 25 healthy volunteers in order to compare with the ILD participants.

Pneumonia
25 patients with pneumonia as a control group.
Other: Pneumonia
100 cc of blood collected from a total of 100 participants with a diagnosis of pneumonia in order to compare with the ILD participants.




Primary Outcome Measures :
  1. Future Disease Management [ Time Frame: 1 visit ]
    Reliable biomarkers to help guide treatment in ILD would be a major step forward in the management of this disease.


Biospecimen Retention:   Samples With DNA

To develop a repository of blood samples from patients with ILD to support future studies into the development of such biomarkers. Patients with pneumonia and healthy patients will also be recruited as a control group. The repository would be maintained in Dr. Carmona's laboratory in the Thoracic Diseases Research Unit in the Stabile building where all biospecimens will be stored.

These samples will be stored in freezers in Dr. Carmona's laboratory space in the Thoracic Diseases Research Unit in the Stabile building for future research.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with a diagnosis of ILD or any fibrotic disease of the lung. A diagnosis of pneumonia and healthy volunteers will also be included as a control group.
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of ILD or any fibrotic disease of the lung or a diagnosis of pneumonia
  • Patients willing to provide written informed consent

Exclusion Criteria:

  • Unwillingness/unable to give blood samples

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): NCT03478826


Contacts
Layout table for location contacts
Contact: Tami Krpata 507-538-1979 krpata.tami@mayo.edu

Locations
Layout table for location information
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Boleyn Andrist    507-284-9946    andrist.boleyn@mayo.edu   
Principal Investigator: Eva Carmona, M.D., Ph.D.         
Sponsors and Collaborators
Mayo Clinic

Layout table for additonal information
Responsible Party: Eva M. Carmona Porquera, Assistant Professor of Medicine, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03478826     History of Changes
Other Study ID Numbers: 17-008088
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD will not be shared at this time, but it may be possible that in the future outside institutions or other researchers within the Mayo Clinic may ask for specimen samples. If a specimen sample is requested, a new protocol will be submitted to the IRB or the IRB application for this study will be amended.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eva M. Carmona Porquera, Mayo Clinic:
ILD

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases