Tumor-specific T Cells in Lung Cancer

July 30, 2023 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

  • Germany
      • 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
Procedure: Bone marrow aspiration from the iliac crest
Device: Illinois bone marrow aspiration neddle
Experimental: Control group (healthy donors)
Bone marrow puncture in healthy donors
Procedure: Bone marrow aspiration from the iliac crest
Device: Illinois bone marrow aspiration neddle

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

University Hospital Heidelberg

Collaborators

German Cancer Research Center
Heidelberg University

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

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)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 30, 2023

Last Verified

July 1, 2023

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.

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