NCT03711435

Brief Summary

The pathogenesis of idiopathic pulmonary interstitial fibrosis is complex, and there is no specific biomarkers, the treatment effect is not such useful. Currently, it is discovered that Chinese medicine treatment may be effective. The investigators select patients with idiopathic pulmonary interstitial fibrosis and healthy controls, use metabolomics to study the biological characteristics of idiopathic pulmonary interstitial fibrosis, screen biomarkers of IPF, and label different TCM syndromes of IPF, explore the biological nature of IPF TCM syndromes, find the biological changes that occur during the development and progression of IPF and explore the metabolite marker clusters of IPF. Furthermore, the results of this study may find its diagnostic significance for IPF and Looking for potential targets for future treatment of IPF.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

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

October 7, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

October 20, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2020

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

1.3 years

First QC Date

October 7, 2018

Last Update Submit

July 20, 2022

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary FibrosisMetabolomicsChinese medicine

Outcome Measures

Primary Outcomes (1)

  • biomarkers detected in metabolites

    Metabolomics of serum based on mass spectrometry.It is non-targeted metabolomics.The study is to find the target metabolite to distinguish IPF.

    1 year

Secondary Outcomes (4)

  • High-resolution chest CT total score (CT-Tot)

    1 year

  • Six Minute Walk Test(6MWT)

    1 year

  • Pulmonary function Pulmonary function

    1 year

  • St. George's Respiratory Questionnaire

    1 year

Study Arms (2)

Training set

The training set is composed of 30 IPF patients and 15 controls. The group is designed to identify differential metabolites between IPF and control groups.

Validation set

The validation set is composed of 15 IPF patients and 15 controls. The group is designed to validate differential metabolites identified in the previous groups.

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

IPF patients in XUZHOU

You may qualify if:

  • According to the diagnostic criteria published in 2015, the New Guidelines for the Diagnosis and Treatment of Idiopathic Pulmonary Fibrosis, jointly developed by the American Thoracic Society, the European Respiratory Society, the Japanese Respiratory Society, and the Latin American Thoracic Society;
  • aged 50 to 85 years old;
  • Health people match on the age (±3 years old) and gender with case group with 1:1 rate at the same time.

You may not qualify if:

  • Those with severe heart, liver, kidney and other organ dysfunction or suffering from blood diseases;
  • with malignant tumors;
  • Severely infected people;
  • Pregnant and lactating women;
  • mental illness, serious obstacles and those who are unwilling to cooperate;
  • Those with severe heart, liver, kidney and other organ dysfunction or blood disease;
  • With malignant tumors;
  • Chest X-ray or chest low-dose CT suggesting intra-pulmonary interstitial fibrosis;
  • With chronic pulmonary diseases such as pulmonary interstitial disease, chronic obstructive pulmonary disease, and bronchial asthma;
  • With connective tissue disease and those with a history of exposure to occupational diseases;
  • Mental illness, serious obstacles and unwilling to cooperate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuzhou Traditional Chinese Medicine Hospital

Xuzhou, Jiangsu, 210029, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Officials

  • YING MS ZHAO, PHD

    Xuzhou Traditional Chinese Medicine Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2018

First Posted

October 18, 2018

Study Start

October 20, 2018

Primary Completion

February 5, 2020

Study Completion

February 5, 2020

Last Updated

July 25, 2022

Record last verified: 2022-07

Locations

CN(1)