NCT02988388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

February 23, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2019

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2019

Completed
Last Updated

March 8, 2019

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

December 7, 2016

Last Update Submit

March 7, 2019

Conditions

Chronic Obstructive Pulmonary DiseaseInterstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

  • Clinical diagnosis

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

    Two months following surgery

Study Arms (1)

Lung biopsy/lobectomy

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

Procedure: Lung biopsy/lobectomy

Interventions

Lung biopsy/lobectomyPROCEDURE

Lung biopsies and lobectomies are not experimental. Participants will undergo a lung biopsy or a lobectomy as part of standard of care.

Lung biopsy/lobectomy

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 14213, United States

Location

Related Publications (1)

  • Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.

    PMID: 35688625DERIVED

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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tom Croxton

    National Heart, Lung, and Blood Institute (NHLBI)

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 9, 2016

Study Start

February 23, 2017

Primary Completion

January 28, 2019

Study Completion

February 21, 2019

Last Updated

March 8, 2019

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

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.

Locations

US(4)