Lung Tissue Research Consortium (LTRC)

• ClinicalTrials.gov Identifier: NCT02988388
• Recruitment Status: Completed
• First Posted: December 9, 2016
• Last Update Posted: March 8, 2019
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information

• First Submitted Date: December 7, 2016
• First Posted Date: December 9, 2016
• Last Update Posted Date: March 8, 2019
• Actual Study Start Date: February 23, 2017
• Actual Primary Completion Date: January 28, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 7, 2016)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Lung Tissue Research Consortium
• Official Title: Lung Tissue Research Consortium
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

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.

• Sampling Method: Non-Probability Sample
• Study Population: Adults ages 21 or older who are undergoing lung surgery for suspected malignancy or metastases.

Condition

• Chronic Obstructive Pulmonary Disease
• Interstitial Lung Disease

Intervention

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.

Study Groups/Cohorts

Lung biopsy/lobectomy

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

Intervention: Procedure: Lung biopsy/lobectomy

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 7, 2019): 247
• Original Estimated Enrollment (submitted: December 7, 2016): 400
• Actual Study Completion Date: February 21, 2019
• Actual Primary Completion Date: January 28, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02988388
• Other Study ID Numbers: LTR01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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.

• Current Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
• Original Responsible Party: Same as current
• Current Study Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: National Heart, Lung, and Blood Institute (NHLBI)
• Verification Date: August 2017