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Tumor-specific T Cells in Lung Cancer

NCT ID: NCT02515760

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2025-09-30

Brief Summary

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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

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Lung cancer group

Bone marrow puncture in patients with non-small cell lung cancer

Group Type EXPERIMENTAL

Bone marrow aspiration from the iliac crest

Intervention Type PROCEDURE

Illinois bone marrow aspiration neddle

Intervention Type DEVICE

Control group (healthy donors)

Bone marrow puncture in healthy donors

Group Type EXPERIMENTAL

Bone marrow aspiration from the iliac crest

Intervention Type PROCEDURE

Illinois bone marrow aspiration neddle

Intervention Type DEVICE

Interventions

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Bone marrow aspiration from the iliac crest

Intervention Type PROCEDURE

Illinois bone marrow aspiration neddle

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Cancer Research Center

OTHER

Sponsor Role collaborator

Heidelberg University

OTHER

Sponsor Role collaborator

University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Dr. med. Seyer Safi

PD Dr. med. Seyer Safi

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seyer Safi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Division Thoracic Surgery, Technical University of Munich, Munich, Germany

Locations

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Division of Thoracic Surgery, Technical University of Munich, Munich, Germany

Munich, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 29617574 (View on PubMed)

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.

Reference Type RESULT
PMID: 33255425 (View on PubMed)

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.

Reference Type RESULT
PMID: 31741774 (View on PubMed)

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.

Reference Type RESULT
PMID: 29147626 (View on PubMed)

Other Identifiers

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S-515/2013

Identifier Type: -

Identifier Source: org_study_id