Tumor-specific T Cells in Lung Cancer

Not Applicable

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Procedure: Bone marrow aspiration from the iliac crest; Device: Illinois bone marrow aspiration neddle

• Registration Number: NCT02515760
• Lead Sponsor: University Hospital Heidelberg

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2015-07-30
• Study First Submitted QC: 2015-08-04
• Study First Posted: 2015-08-05
• Primary Completion: 2018-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-08
• Last Update Posted: 2024-12-12
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lung cancer group	Bone marrow aspiration from the iliac crest	Bone marrow puncture in patients with non-small cell lung cancer
Control group (healthy donors)	Illinois bone marrow aspiration neddle	Bone marrow puncture in healthy donors
Lung cancer group	Illinois bone marrow aspiration neddle	Bone marrow puncture in patients with non-small cell lung cancer
Control group (healthy donors)	Bone marrow aspiration from the iliac crest	Bone marrow puncture in healthy donors

Primary Outcome Measures

Name	Time	Method
Frequencies of tumor-specific T cells	2 weeks postoperative	% of all T cells

Secondary Outcome Measures

Name	Time	Method
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	2 weeks postoperative	location: peripheral versus bone marrow
Long-term survival	5 years postoperative	OS

Trial Locations

Locations (1)

Division of Thoracic Surgery, Technical University of Munich, Munich, Germany; 🇩🇪 Munich, Germany