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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02988388
Other study ID # LTR01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 23, 2017
Est. completion date February 21, 2019

Study information

Verified date August 2017
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 247
Est. completion date February 21, 2019
Est. primary completion date January 28, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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.

Study Design


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.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Temple University Philadelphia Pennsylvania
United States University of Pittsburgh Pittsburgh Pennsylvania
United States Mayo Clinic Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical diagnosis A final diagnosis of the participant's lung disease will be rendered by the clinical center PI. Two months following surgery
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