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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05982574
Other study ID # S-515/2013 S-270/2001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 2016
Est. completion date December 2026

Study information

Verified date May 2024
Source University Hospital Heidelberg
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cancer immunotherapy has the great potential to achieve long-term survival in patients with a solid malignancy. However, the beneficial effect of cancer immunotherapy is seen in only a minority of patients. Mounting evidence suggests that immunosuppressive features in the tumor microenvironment prevent an effective antitumor defense. The aim of the investigators is to comprehensively analyze the cytokine profile and the tumor immune infiltrate in the tumor microenvironment and to investigate its prognostic significance in patients with radically resected lung adenocarcinoma.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date December 2026
Est. primary completion date February 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Lung adenocarcinoma - Tumor stage IB and II - With or without adjuvant therapy - Complete surgical resection (R0) - No distant metastasis at the time of surgery (M0) Exclusion Criteria: • Second cancer within 5 years

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Heidelberg

References & Publications (3)

Beck C, Ramanujam D, Vaccarello P, Widenmeyer F, Feuerherd M, Cheng CC, Bomhard A, Abikeeva T, Schadler J, Sperhake JP, Graw M, Safi S, Hoffmann H, Staab-Weijnitz CA, Rad R, Protzer U, Frischmuth T, Engelhardt S. Trimannose-coupled antimiR-21 for macropha — View Citation

Safi S, Messner L, Kliebisch M, Eggert L, Ceylangil C, Lennartz P, Jefferies B, Klein H, Schirren M, Dommasch M, Lobinger D, Multhoff G. Circulating Hsp70 Levels and the Immunophenotype of Peripheral Blood Lymphocytes as Potential Biomarkers for Advanced — View Citation

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 C — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival Association of tumor microenvironment with overall survival From date of surgery until the date of death from any cause assessed up to 100 months
Secondary Recurrence-free survival Association of tumor microenvironment with recurrence-free survival From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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