Recruiting

Pulmonary Fibrosis

Sponsor:

University of Virginia

Code:

NCT06323876

Conditions

Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

HRCT

Blood Draw

Study Details

Brief summary:

This observational study involves obtaining 2 chest CT scans; a historical baseline CT within ±1 year of enrollment into PRECISIONS, and a follow-up CT (either historical or prospective) 12 months ± 180 days after the baseline CT. Many IPF patients will have a CT scan every 12 months for disease monitoring and cancer screening. Participants will have the option to share historical CTs only or they can choose to have a research CT done for the follow-up scan, if a scan for clinical purposes is not available.

Conditions

Idiopathic Pulmonary Fibrosis

Study ID

NCT06323876

Start date

Jun 20, 2024

Status verified date

Aug, 2024

Completion date

May, 2029

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. ≥ 40 years of age
2. Diagnosed with IPF according to 2018 ATS/ERS/JRS/ALAT confirmed by the enrolling investigator
3. Signed informed consent

Exclusion Criteria:

1. Pregnancy or planning to become pregnant
2. Women of childbearing potential not willing to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of <1% per year during study participation\*
3. Significant medical, surgical or psychiatric illness that in the opinion of the investigator would affect subject safety or potential to complete the research study

  • A woman is considered to be of childbearing potential if she is post-monarchical, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).

Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilization, established and proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

University of Chicago

This cohort will have prior consent to the Natural History of Interstitial Lung Disease, which is an ongoing, longitudinal cohort of patients with clinically diagnosed ILD, including IPF. Patients are recruited from University of Chicago Interstitial Lung Disease Program during their clinic visit. Blood, plasma, and serum samples are collected upon enrollment and stored in a biorepository at University of Chicago. Subsets of patients have repeat blood draw at return clinic visits for specific research studies. The investigators propose collection of 1-year HRCTs, FVC, and DLCO.

University of Virginia

This cohort will have prior consent to the Natural History of Interstitial Lung Disease, which is an ongoing, longitudinal cohort of patients with clinically diagnosed ILD, including IPF. Patients are recruited from the UVA Interstitial Lung Disease Program during their clinic visit. Blood, plasma, and serum samples are collected upon enrollment and stored in a biorepository at UVA (Pinn Hall RM#2232B, IRB#20937). Subsets of patients have repeat blood draw at return clinic visits for specific research studies. The investigators propose collection of 1-year HRCTs, FVC, and DLCO.

Interventions

HRCT

High resolution computed tomography (HRCT) scan is a medical imaging technique used to obtain detailed internal images of the body. HRCT images will be obtained at 0 and 12 months.

Blood Draw

During blood draw, someone uses a needle to take blood from a vein, usually in your arm.

Primary outcome measure

  • Derivation of DTA in IPF only cases from the PFF-PR and its associations with disease severity and outcomes. [ Time Frame: 12 months ]
  • Determine whether known IPF-risk genetic variants are associated with DTA score. [ Time Frame: 12 months ]
  • Identify novel genetic variants that associate with DTA score progression. [ Time Frame: 12 months ]
  • Determine if DTA or any constituent radiomic features correlate with select plasma proteins. [ Time Frame: 12 months ]
  • Determine if DTA or any of constituent radiomic features correlate with transcriptomic [ Time Frame: 12 months ]
  • Determine the best combination of markers (DTA, proteins and transcriptome) for machine learning algorithms for AUC evaluation of ROCs on all 3 cohorts. [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Roselove Nunoo-Asare

4342436074rnn3b@uvahealth.org

Diana Hsu, MA

NBR2DF@uvahealth.org

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Roselove Asare, MA

434-243-6074rnn3b@uvahealth.org

Diana Hsu, MA

NBR2DF@uvahealth.org

Principal Investigator:

Imre Noth, MD

More Information

Sponsor

University of Virginia

Last update posted

Aug 16, 2024

Last verified

Aug, 2024

Keywords

  • CT
  • biomarkers
  • gene expression
  • radiomic markers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2024-08-16.