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

• Sponsor: University of Vienna (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04827667
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 9.5
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Diagnostic Test: bronchoalveolar lavage

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 Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact of PD1-lymphocytes in Bronchoalveolar Lavage of Patients With Lung Cancer
• Actual Study Start Date: Mar 18, 2021
• Anticipated Primary Completion Date: Sep 30, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniela Gompelmann, Prof. Dr. med., University of Vienna
• ClinicalTrials.gov Identifier: NCT04827667
• Other Study ID Numbers: Version 1 20.04.2020
• First Posted: Apr 1, 2021
• Last Update Posted: Apr 6, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Dimercaprol

Study Results

No Results Posted as of Apr 6, 2021