- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04827667
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
- Name: Daniela Gompelmann
- Phone Number: 0043 1 40400 47730
- Email: daniela.gompelmann@meduniwien.ac.at
Study Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- Medical University of Vienna
-
Contact:
- Daniela Gompelmann
- Phone Number: 0043 1 40400 47730
- Email: daniela.gompelmann@meduniwien.ac.at
-
-
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.
|
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.
|
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.
|
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
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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