We aim to explore the feasibility of immunological cell typing of endobronchial ultrasound (EBUS) guided fine needle aspirates (FNA) of lymph nodes and to develop immunodynamic biomarkers during SABR treatment.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For the exploration part: difference in the percentage and ratio of immune
cells between tumor draining lymph nodes (TDLNs), non-tumor draining lymph
nodes (NTDLNs), bronchial wash and peripheral blood. For the qualification
part: change in the percentage, activation status and ratio of selected immune
cells in TDLNs and NTDLNs after SABR treatment as compared to baseline.
Secondary outcome
not applicable
Background summary
A recent matched cohort analysis showed a higher locoregional control rate for
stereotactic ablative radiotherapy (SABR) as compared to video-assisted
thoracoscopic (VATS) lobectomy for early stage non-small-cell lung cancer
(NSCLC) with a trend towards better overall survival. The unexpected difference
in locoregional recurrence may be related to an immunological response. We
hypothesize that, in addition to the tumor itself, the draining lymph nodes of
the primary tumor are the most relevant location to search for the presence of
immunomodulation.
Study objective
We aim to explore the feasibility of immunological cell typing of endobronchial
ultrasound (EBUS) guided fine needle aspirates (FNA) of lymph nodes and to
develop immunodynamic biomarkers during SABR treatment.
Study design
Pilot exploratory study with biomarker exploration, followed by biomarker
qualification.
During the exploration and validation step 10 patients will undergo an
endoscopy as part of their regular diagnostic workup. EBUS-FNA of the lymph
nodes and a bronchial wash will be performed and blood drawn to compare the
distribution of immune effector cell subsets between blood, tumor and lymph
nodes and to identify the most interesting and feasible cell subsets to focus
on for the qualification phase. During the qualification step 10 patients will
undergo an endoscopy before and after SABR treatment to identify changes in the
immune effector cell subsets.
Study burden and risks
The burden and risks associated with participation are considered low.
Bronchoscopy with ultrasound is used in daily practice and is not associated
with significant complications. Patients who will be approached for study
participation already have an indication for a pretreatment EBUS procedure. The
posttreatment endoscopy after SABR in the qualification phase of this study is
however not part of regular care and is performed for the purpose of this
study.
De Boelelaan 1117
Amsterdam 1007 MB
NL
De Boelelaan 1117
Amsterdam 1007 MB
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50035.029.14 |