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Tumor-specific T Cells in Lung Cancer

Sponsor
University Hospital Heidelberg (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02515760
Collaborator
German Cancer Research Center (Other), Heidelberg University (Other)
120
Enrollment
1
Location
2
Arms
127
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bone marrow aspiration from the iliac crest
  • Device: Illinois bone marrow aspiration neddle
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Tumor-specific Effector T Cells in Non-small Cell Lung Cancer
Study Start Date :
Feb 1, 2014
Actual Primary Completion Date :
Jun 1, 2018
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Frequencies of tumor-specific T cells [2 weeks postoperative]

    % of all T cells

Secondary Outcome Measures

  1. 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

  2. Long-term survival [5 years postoperative]

    OS

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Division of Thoracic Surgery, Technical University of Munich, Munich, Germany Munich Germany 81675

Sponsors and Collaborators

  • University Hospital Heidelberg
  • German Cancer Research Center
  • Heidelberg University

Investigators

  • Principal Investigator: Seyer Safi, MD, PhD, Division Thoracic Surgery, Technical University of Munich, Munich, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. med. Seyer Safi, PD Dr. med. Seyer Safi, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT02515760
Other Study ID Numbers:
  • S-515/2013
First Posted:
Aug 5, 2015
Last Update Posted:
May 20, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of May 20, 2022