Tumor Microenvironment

NCT05982574 | Active Not Recruiting

• 1 other identifier: S-515/2013 S-270/2001
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lung Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with completely resected lung adenocarcinoma stage IB and II

You may qualify if:

• 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)

You may not qualify if:

• Second cancer within 5 years

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Related 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 macrophage-targeted inhalation treatment of acute inflammatory lung damage. Nat Commun. 2023 Jul 28;14(1):4564. doi: 10.1038/s41467-023-40185-1.

  PMID: 37507393 RESULT

• 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 Lung Cancer and Therapy Failure after Surgery. Biomolecules. 2023 May 22;13(5):874. doi: 10.3390/biom13050874.

  PMID: 37238744 RESULT

• 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.

  PMID: 33255425 RESULT

MeSH Terms

Conditions

Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Study Officials

• Seyer Safi, MD

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Seyer Safi

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 8, 2023
• Study Start: February 1, 2016
• Primary Completion: February 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-05