Tumor Microenvironment

Lung Adenocarcinoma Clinical Trial

Official title:

Tumor Microenvironment in Lung Adenocarcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05982574
• Other study ID #: S-515/2013 S-270/2001
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Lung Adenocarcinoma

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