NCT04827667

Brief Summary

The aim of this trial is to assess PD1-lymphocytes in bronchoalveolar lavage in patients with lung cancer, ILD and asthma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 18, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

March 29, 2021

Last Update Submit

April 4, 2021

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • To assess and compare PD1-lmyphocytes in bronchoalveolar lavage in patients with malignant and benign lung diseases to evluate their impact in lung cancer patients

    6 months

Study Arms (3)

Patients with lung cancer

In lung cancer patients with indication for bronchoscopy, bronchoalveolar lavage is performed to assess PD1-lymphocytes.

Diagnostic Test: bronchoalveolar lavage

Patients wiht interstitial lung disease

In patients with interstitial lung disease with indication for bronchoscopy, bronchoalveolar lavage is performed to assess PD1-lymphocytes.

Diagnostic Test: bronchoalveolar lavage

Patients with asthma

In patients with asthma with indication for bronchoscopy, bronchoalveolar lavage is performed to assess PD1-lymphocytes.

Diagnostic Test: bronchoalveolar lavage

Interventions

bronchoalveolar lavageDIAGNOSTIC_TEST

Bronchoalveolar lavage is performed by instillation and suction of saline in the middle lobe during bronchoscopy. Cytological examination and flow cytometry will be performed to assess PD-1lymphoctes.

Patients wiht interstitial lung diseasePatients with asthmaPatients with lung cancer

Eligibility Criteria

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

Patients with suspected or proven lung cancer, asthma or instertitial lung disease

You may qualify if:

  • age \>18 years
  • patients with lung cancer, asthma or ILD and indication for bronchoscopy for medical reasons
  • Ability to provide informed consent

You may not qualify if:

  • acute excacerbation in patients with asthma or ILD
  • endoluminal tumor growth or penumonia in patients with lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Daniela Gompelmann

CONTACT

0043 1 40400 47730daniela.gompelmann@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 1, 2021

Study Start

March 18, 2021

Primary Completion

September 30, 2021

Study Completion

December 31, 2021

Last Updated

April 6, 2021

Record last verified: 2021-04

Locations

AU(1)