NCT06275295

Brief Summary

The goal of this observational study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC） in progressive pulmonary fibrosis.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

February 17, 2024

Last Update Submit

February 17, 2024

Conditions

Pulmonary FibrosisTransbronchial Cryobiopsy

Outcome Measures

Primary Outcomes (1)

  • The diagnostic rate of MDD2 based on TBLC

    the diagnostic rate of progressive pulmonary fibrosis after Transbronchial Cryobiopsy

    December，31，2024

Secondary Outcomes (1)

  • The diagnostic rate of MDD1

    December，31，2024

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients receiving TBLC for progressive pulmonary fibrosis

You may qualify if:

  • Patients with PPF, ≥18 years of age, unclassified ILD, HRCT ≤3 months, forced vital capacity (FVC)≥50% predicted value, pulmonary carbon monoxide diffusion (DLCO)≥35% predicted value, echocardiography ≤12 months, estimated pulmonary systolic blood pressure ≤40 mmHg, Body mass index (BMI)≤35 kg/m2.

You may not qualify if:

  • Patients with platelet counts below 50,000e+9/L or International Normalized ratio of prothrombin time (INR) above 1.5 are not eligible for TBLC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Gang Hou, Professor

CONTACT

1384005481hougangcmu@163.com

Mingming Deng, PhD

CONTACT

+86 18801336854isdeng@163.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 17, 2024

First Posted

February 23, 2024

Study Start

March 20, 2024

Primary Completion

December 24, 2024

Study Completion

December 31, 2024

Last Updated

February 23, 2024

Record last verified: 2024-02