NCT03917485

Brief Summary

The main purpose of this study is to update the pulmonary retention values of non-fibrous mineral particles in the general population. This study will provide reference values for the interpretation and diagnosis of the cause of certain respiratory diseases potentially related to mineral particles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Longer than P75 for all trials

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

Study Start

First participant enrolled

December 5, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

4.5 years

First QC Date

April 4, 2019

Last Update Submit

September 4, 2023

Conditions

Occupational Exposure

Outcome Measures

Primary Outcomes (1)

  • Number of non fibrous mineral particles in LBA (Bronchoalveolar lavage) (nombre of particles by ml)

    Quantitative analysis of Non Fibrous Mineral Particles on samples obtained from subjects selected free from any significant occupational or environmental exposure to Non-fibrous Mineral Particle.

    1 month

Secondary Outcomes (2)

  • Name of non fibrous mineral particles in LBA (Bronchoalveolar lavage) (nombre of particules by ml)

    1 month

  • seize of non fibrous mineral particles in LBA (Bronchoalveolar lavage)

    1 month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects not exposed to Non-fibrous Mineral Particle in a professional and / or environmental way

You may qualify if:

  • Subjects not exposed to Non-fibrous Mineral Particle in a professional and / or environmental way.
  • Smokers and non-smokers (or weaners who have been weaned for at least 5 years).
  • Acceptance to participate in the protocol.
  • Affiliated to a social security scheme.

You may not qualify if:

  • Suspicion of fibrosing pulmonary pathologies.
  • Suspicion of pulmonary sarcoidosis ≥ stage 2, pneumoconiosis.
  • Subjects with cystic fibrosis.
  • Subjects chronic obstructive pulmonary disease (COPD) stage ≥ 3.
  • Presence of serious comorbidities that are life-threatening in the short term.
  • Refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Intercommunal de Créteil

Créteil, 94010, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Broncho-Alveolar Washing Fluid

Study Design

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

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 17, 2019

Study Start

December 5, 2018

Primary Completion

June 2, 2023

Study Completion

June 2, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)