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Tumor Microenvironment

Sponsor
University Hospital Heidelberg (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05982574
Collaborator
(none)
300
Enrollment
118
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Tumor Microenvironment in Lung Adenocarcinoma
    Actual Study Start Date :
    Feb 1, 2016
    Anticipated Primary Completion Date :
    Feb 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. 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

    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]

      Association of tumor microenvironment with recurrence-free survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital Heidelberg

    Investigators

    • Principal Investigator: Seyer Safi, MD, Technical University of Munich

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. med. Seyer Safi, PD Dr. Seyer Safi, University Hospital Heidelberg
    ClinicalTrials.gov Identifier:
    NCT05982574
    Other Study ID Numbers:
    • S-515/2013 S-270/2001
    First Posted:
    Aug 8, 2023
    Last Update Posted:
    Aug 8, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenocarcinoma
    Adenocarcinoma of Lung

    Study Results

    No Results Posted as of Aug 8, 2023