Tumor Microenvironment

Active, not recruiting

• Conditions: Lung Adenocarcinoma

• Registration Number: NCT05982574
• Lead Sponsor: University Hospital Heidelberg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2023-07-30
• Study First Submitted QC: 2023-08-05
• Study First Posted: 2023-08-08
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2026-02
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	From date of surgery until the date of death from any cause assessed up to 100 months	Association of tumor microenvironment with overall survival

Secondary Outcome Measures

Name	Time	Method
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	Association of tumor microenvironment with recurrence-free survival