Impact of PD1-lymphocytes in Bronchoalveolar Lavage of Patients With Lung Cancer

April 4, 2021 updated by: Daniela Gompelmann, University of Vienna
The aim of this trial is to assess PD1-lymphocytes in bronchoalveolar lavage in patients with lung cancer, ILD and asthma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this trial, 20 patients with lung cancer, 10 patients with asthma and 10 patients with interstitial lung disease who have to undergo bronchocospy for medical reasons are enrolled. In each patient, bronchoalveolar lavage is performed to assess PD1-lymphocytes.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with lung cancer
In lung cancer patients with indication for bronchoscopy, bronchoalveolar lavage is performed to assess PD1-lymphocytes.
Diagnostic test: bronchoalveolar lavage
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 disease
In patients with interstitial lung disease with indication for bronchoscopy, bronchoalveolar lavage is performed to assess PD1-lymphocytes.
Diagnostic test: bronchoalveolar lavage
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 with asthma
In patients with asthma with indication for bronchoscopy, bronchoalveolar lavage is performed to assess PD1-lymphocytes.
Diagnostic test: bronchoalveolar lavage
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2021

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 4, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version 1 20.04.2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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