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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
Sponsor:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)

Study Description
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Brief Summary:
The LTRC will facilitate histopathological research of pulmonary diseases by collecting lung tissues from donors and preparing and distributing collections of tissue specimens to researchers within and outside the LTRC. Collections of specimens will be linked to individual clinical data appropriate to the particular disease. The primary goal of the LTRC is to identify participants with suspected lung cancer or metastatic disease who are willing to provide informed consent for research use of their specimens and data. Secondarily, the LTRC investigators intend to collect clinical data, limited exposure data, physiologic studies, and radiographic studies from these participants.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Interstitial Lung Disease Procedure: Lung biopsy/lobectomy

Study Design
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Study Type : Observational
Actual Enrollment : 247 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Lung biopsy/lobectomy
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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
For a subset of LTRC participants who provide applicable consent, a portion of collected blood will be stored in a Paxgene DNA tube for DNA generation. DNA will be stored in a central laboratory and available for request by qualified researchers.

Eligibility Criteria
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Information from the National Library of Medicine

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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
Study Population
Adults ages 21 or older who are undergoing lung surgery for suspected malignancy or metastases.
Criteria

Inclusion Criteria:

  • Adults ages 21 or older who are undergoing lung surgery for suspected malignancy or metastases.

Exclusion Criteria:

  • Diagnosis of cystic fibrosis or pulmonary hypertension.
  • Any other condition that, in the judgment of the investigator, precludes participation.
  • Failure to obtain written consent.
Contacts and Locations
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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): NCT02988388


Locations
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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
Temple University
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 14213
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Study Director: Tom Croxton National Heart, Lung, and Blood Institute (NHLBI)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT02988388    
Other Study ID Numbers: LTR01
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Interstitial
Respiratory Tract Diseases