LTRC: Lung Tissue Research Consortium

• Sponsor: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT02988388
• Collaborator: (none)
• Enrollment: 247
• Locations: 4
• Actual Duration (Months): 23.9
• Patients Per Site: 61.8
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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	Phase
Chronic Obstructive Pulmonary Disease; Interstitial Lung Disease	Procedure: Lung biopsy/lobectomy

Study Design

• 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: Feb 23, 2017
• Actual Primary Completion Date: Jan 28, 2019
• Actual Study Completion Date: Feb 21, 2019

Arms and Interventions

Arm	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

Primary Outcome Measures

1. Clinical diagnosis [Two months following surgery]

   A final diagnosis of the participant's lung disease will be rendered by the clinical center PI.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109
2	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905
3	Temple University	Philadelphia	Pennsylvania	United States	19140
4	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	14213

Sponsors and Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Study Director: Tom Croxton, National Heart, Lung, and Blood Institute (NHLBI)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
• ClinicalTrials.gov Identifier: NCT02988388
• Other Study ID Numbers: LTR01
• First Posted: Dec 9, 2016
• Last Update Posted: Mar 8, 2019
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial

Study Results

No Results Posted as of Mar 8, 2019