Immunological profiling of hilar and mediastinal lymph nodes in lung cancer patients

Completed

• Conditions: 10038666; lung cancer; pulmonary malignancy

• Registration Number: NL-OMON41899
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

* Be willing and able to provide written informed consent for the study.
* Be 18 years of age or older on the day of signing informed consent.
* A (suspected) diagnosis of NSCLC.
* For the exploration and validation part TNM stage cTxN1-2Mx.
* For the qualification part TNM stage cT1-2aN0M0 and planned for SABR
treatment.
* At least one lymph node with a minimal short axis diameter of 10 mm.
* Eligible to undergo an EBUS procedure according to the treating physician
and international guidelines.
* Able to undergo an EBUS procedure according to institutional guidelines.

Exclusion Criteria

* Active infection requiring systemic therapy.
* A diagnosis of immunodeficiency or is receiving systemic steroid
therapy or any other form of immunosuppressive therapy within 7 days prior
to the first dose of trial treatment.
* A known additional malignancy that is progressing or requires active treatment.
Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in
situ cervical cancer that has undergone potentially curative therapy.
* Major surgery or blood transfusions in the past 3 months.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For the exploration part: difference in the percentage and ratio of immune<br /><br>cells between tumor draining lymph nodes (TDLNs), non-tumor draining lymph<br /><br>nodes (NTDLNs), bronchial wash and peripheral blood. For the qualification<br /><br>part: change in the percentage, activation status and ratio of selected immune<br /><br>cells in TDLNs and NTDLNs after SABR treatment as compared to baseline.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>