Bio-Banking of Specimens for Advanced Lung Disease and Lung Transplant Research

NCT04664192 | Recruiting

• 1 other identifier: 021-007
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A major goal of this protocol is to support biomarker studies in advanced lung diseases, lung transplantation care, and to improve our understanding of the effects of viral and other infectious exposures to outcomes in our lung transplant and ALD patient populations.

Conditions

Respiratory Failure; Interstitial Lung Disease; Lung Diseases

Outcome Measures

Primary Outcomes (1)

• Diagnosis of patients with lung transplant

  ICD 10 code for underlying lung disease

  5 years

Secondary Outcomes (1)

• Survival

  5 years

Study Arms (1)

Lung transplant Recipients

Biobank registry for Lung transplant recipients

Other: Patient Biospecimen Registry (observational and blood sampling)

Interventions

Patient Biospecimen Registry (observational and blood sampling) OTHER

Clinical data collected at every blood sample collection visit.

Lung transplant Recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lung transplant recipients

You may qualify if:

• All individuals aged 18 years and older
• Persons who have undergone lung transplantation at Baylor University Medical Center in the previous 10 years
• Individual is able to understand and sign the informed consent form

You may not qualify if:

• Significant documented anemia (hemoglobin \<8 g/dL)
• Blood transfusions within past 3 weeks
• Active cancer (non-skin cancers)
• Enrollment against doctor recommendation
• Patient not able to provide informed consent

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White Research Institute

Dallas, Texas, 75246, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, serum samples, plasma samples

MeSH Terms

Conditions

Respiratory Insufficiency; Lung Diseases, Interstitial; Lung Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Susan Mathai, MD

  Baylor Scott & White Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Mathai, MD

CONTACT

214-820-6856; Susan.Mathai@bswhealth.org

Tammy Fischer

CONTACT

Tammy.Fisher@BSWHealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary Disease specialist

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 11, 2020
• Study Start: June 4, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)