Tumor-specific T Cells in Lung Cancer
December 8, 2024 updated by: Dr. med. Seyer Safi, University Hospital Heidelberg
Tumor-specific Effector T Cells in Non-small Cell Lung Cancer
Non-small cell lung cancer is characterized by aggressive growth and treatment resistance.
New approaches include immunotherapeutic strategies but spontaneous immune responses against tumor antigens remain unclear.
The aim of this study is to characterize localization and frequencies of spontaneously induced memory T cells specific for a panel of tumor-associated antigens in peripheral blood and bone marrow of non-small cell lung cancer patients.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Munich, Germany, 81675
- Division of Thoracic Surgery, Technical University of Munich, Munich, Germany
-
-
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 to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients with histology proven non-small cell lung cancer or a lesion suspicious of non-small cell lung cancer (lung cancer group)
- Healthy donors (control group)
- written informed consent
Exclusion Criteria:
- Autoimmune disease
- Patients receiving immunomodulatory drugs, e.g. tacrolimus
- Prior malignancy
- Pregnancy
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
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lung cancer group
Bone marrow puncture in patients with non-small cell lung cancer
|
|
|
Experimental: Control group (healthy donors)
Bone marrow puncture in healthy donors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequencies of tumor-specific T cells
Time Frame: 2 weeks postoperative
|
% of all T cells
|
2 weeks postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tumor-specific T cells location determined by Enzyme Linked Immuno Spot Assay (ELISPOT) analysis of peripheral blood and bone marrow samples from the same patient
Time Frame: 2 weeks postoperative
|
location: peripheral versus bone marrow
|
2 weeks postoperative
|
|
Long-term survival
Time Frame: 5 years postoperative
|
OS
|
5 years postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Seyer Safi, MD, PhD, Division Thoracic Surgery, Technical University of Munich, Munich, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yamauchi Y, Safi S, Blattner C, Rathinasamy A, Umansky L, Juenger S, Warth A, Eichhorn M, Muley T, Herth FJF, Dienemann H, Platten M, Beckhove P, Utikal J, Hoffmann H, Umansky V. Circulating and Tumor Myeloid-derived Suppressor Cells in Resectable Non-Small Cell Lung Cancer. Am J Respir Crit Care Med. 2018 Sep 15;198(6):777-787. doi: 10.1164/rccm.201708-1707OC.
- Safi S, Yamauchi Y, Hoffmann H, Weichert W, Jost PJ, Winter H, Muley T, Beckhove P. Circulating Interleukin-4 Is Associated with a Systemic T Cell Response against Tumor-Associated Antigens in Treatment-Naive Patients with Resectable Non-Small-Cell Lung Cancer. Cancers (Basel). 2020 Nov 24;12(12):3496. doi: 10.3390/cancers12123496.
- Safi S, Yamauchi Y, Stamova S, Rathinasamy A, Op den Winkel J, Junger S, Bucur M, Umansky L, Warth A, Herpel E, Eichhorn M, Winter H, Hoffmann H, Beckhove P. Bone marrow expands the repertoire of functional T cells targeting tumor-associated antigens in patients with resectable non-small-cell lung cancer. Oncoimmunology. 2019 Oct 23;8(12):e1671762. doi: 10.1080/2162402X.2019.1671762. eCollection 2019.
- Safi S, Yamauchi Y, Rathinasamy A, Stamova S, Eichhorn M, Warth A, Rauch G, Dienemann H, Hoffmann H, Beckhove P. Functional T cells targeting tumor-associated antigens are predictive for recurrence-free survival of patients with radically operated non-small cell lung cancer. Oncoimmunology. 2017 Sep 8;6(11):e1360458. doi: 10.1080/2162402X.2017.1360458. eCollection 2017.
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
February 1, 2014
Primary Completion (Actual)
June 1, 2018
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
July 30, 2015
First Submitted That Met QC Criteria
August 4, 2015
First Posted (Estimated)
August 5, 2015
Study Record Updates
Last Update Posted (Actual)
December 12, 2024
Last Update Submitted That Met QC Criteria
December 8, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-515/2013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.