Telomeres Length in Israeli Fibrotic ILD Patients

NCT06885515 | Enrolling By Invitation

• 1 other identifier: BRZ-0050-24
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Individuals with fibrotic interstitial lung diseases (FILD) will be recruited after providing informed consent. in addition to routine data as usually collected in the clinic, blood samples will be taken for measurement of telomeres length in peripheral blood leukocytes using both the Telomere Restriction Fragment (TRF) Analysis method and Nanopore sequencing. Participants with FILD will be followed-up for 2-year after recruitment, including clinical and pulmonary function tests at-least every 6 months, or more frequently, according to the treating physician discretion.

Conditions

Pulmonary Fibrosis

Keywords

pulmonary fibrosis; familial interstitial lung disease; familial pulmonary fibrosis

Outcome Measures

Primary Outcomes (1)

• the prevalence of short LTL among Israeli patients with familial and sporadic FILD.

  the prevalence of short LTL among Israeli patients with familial and sporadic FILD.

  1 year

Secondary Outcomes (6)

• Composite prospective outcome

  2-year

• lung transplantation

  2-year

• forced vital capacity (FVC) decline ≥5%

  2 year

• criteria for progressive pulmonary fibrosis (PPF)

  2 year

• All cause mortality

  2 year

Study Arms (3)

familial pulmonary fibrosis

Patients with familial pulmonary fibrosis are those with at-least one first-degree or second-degree relative with FILD

Diagnostic Test: leukocyte telomere length (LTL) will be measured using the Telomere Restriction Fragment (TRF) Analysis method

non familial pulmonary fibrosis

Patients with pulmonary fibrosis without relatives with FILD

Diagnostic Test: leukocyte telomere length (LTL) will be measured using the Telomere Restriction Fragment (TRF) Analysis method

control

10 healthy age-matched controls with no personal or family history of lung disease will be recruited as well

Diagnostic Test: leukocyte telomere length (LTL) will be measured using the Telomere Restriction Fragment (TRF) Analysis method

Interventions

leukocyte telomere length (LTL) will be measured using the Telomere Restriction Fragment (TRF) Analysis method DIAGNOSTIC_TEST

Peripheral blood leukocytes telomere length will be measured both by TRF analysis and by Nanopore sequencing. Both analyses will be conducted at the laboratory of Prof. Yehuda Tzfati at the Hebrew University, which is highly experienced in the field of telomere biology and in telomere length analysis. Blood samples will be taken once from each participant. No genetic sequencing will be performed as part of this study.

control; familial pulmonary fibrosis; non familial pulmonary fibrosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 90 patients with FILD will be recruited . This cohort will include 30 patients with familial pulmonary fibrosis and 60 with sporadic lung fibrosis. Patients with familial pulmonary fibrosis are those with at-least one first-degree or second-degree relative with FILD. 10 healthy age-matched controls with no personal or family history of lung disease will be recruited as controls.

You may qualify if:

• Adult subjects, aged ≥18-years-old
• Able and willing to provide informed consent to participate in the study
• Lung fibrosis evident on chest CT (signs of honeycombing and/or traction bronchiectasis) \[17\]
• Subjects fulfilling criteria 1 and 2 but with no evidence of chronic lung disease will serve as controls

You may not qualify if:

• Subjects with sarcoidosis as the etiology for FILD
• Subjects who had undergone lung transplantation
• Pregnant women

Sponsors & Collaborators

• Barzilai Medical Center: lead
• Tel Aviv Medical Center: collaborator
• Israel Society of Pulmonology: collaborator

Study Sites (2)

Barzilai Medical Center

Ashkelon, Israel

Location

Tel Aviv Medical Center

Tel Aviv, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ori Wand, Dr.

  Barzilai University Medical Canter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Division of Pulmonary Medicine

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 20, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: December 31 2027-December 31 2030
• Access Criteria: after reasonable request from PI

Locations

IL (2)