Lung Tissue Research Consortium (LTRC)
|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.|
|ClinicalTrials.gov Identifier: NCT02988388|
Recruitment Status : Completed
First Posted : December 9, 2016
Last Update Posted : March 8, 2019
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|Condition or disease||Intervention/treatment|
|Chronic Obstructive Pulmonary Disease Interstitial Lung Disease||Procedure: Lung biopsy/lobectomy|
|Study Type :||Observational|
|Actual Enrollment :||247 participants|
|Official Title:||Lung Tissue Research Consortium|
|Actual Study Start Date :||February 23, 2017|
|Actual Primary Completion Date :||January 28, 2019|
|Actual Study Completion Date :||February 21, 2019|
Adults ages 21 or older who are undergoing lung surgery for suspected malignancy or metastases.
Procedure: Lung biopsy/lobectomy
Lung biopsies and lobectomies are not experimental. Participants will undergo a lung biopsy or a lobectomy as part of standard of care.
- Clinical diagnosis [ Time Frame: Two months following surgery ]A final diagnosis of the participant's lung disease will be rendered by the clinical center PI.
Biospecimen Retention: Samples With DNA
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.
|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- Adults ages 21 or older who are undergoing lung surgery for suspected malignancy or metastases.
- Diagnosis of cystic fibrosis or pulmonary hypertension.
- Any other condition that, in the judgment of the investigator, precludes participation.
- Failure to obtain written consent.
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): NCT02988388
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Minnesota|
|Mayo Clinic Rochester|
|Rochester, Minnesota, United States, 55905|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19140|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 14213|
|Study Director:||Tom Croxton||National Heart, Lung, and Blood Institute (NHLBI)|
|Responsible Party:||National Heart, Lung, and Blood Institute (NHLBI)|
|Other Study ID Numbers:||
|First Posted:||December 9, 2016 Key Record Dates|
|Last Update Posted:||March 8, 2019|
|Last Verified:||August 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Qualified researchers may submit an application for access to LTRC participant data including clinical and pathological diagnoses, radiological images (CT scans) and diagnoses, environmental and occupational exposure questionnaires, respiratory questionnaires and assessments, pulmonary function testing, concomitant therapy, medical history, smoking history, and laboratory measures. Gene array data are also available for a subset of participants. All data are de-identified. No protected health information is released to researchers external to LTRC.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Interstitial
Respiratory Tract Diseases