Lung AdenocarcinomaNCT05982574
Tumor Microenvironment
An observational study of Lung Adenocarcinoma, run by University Hospital Heidelberg.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Adenocarcinoma
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with completely resected lung adenocarcinoma stage IB and II
Who may be able to join
- 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)
Who cannot join
- Second cancer within 5 years
About this study
Official title: Tumor Microenvironment in Lung Adenocarcinoma
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
- Medical subject headings
- Adenocarcinoma of Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Association of tumor microenvironment with overall survival
Measured: From date of surgery until the date of death from any cause assessed up to 100 months
Secondary outcomes (1)
Recurrence-free survival
Association of tumor microenvironment with recurrence-free survival
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study startFeb 2016
- Primary completionFeb 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Seyer Safi, University Hospital Heidelberg
- Investigators
- Seyer Safi, MD, Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982574
- Sponsor's protocol ID
- S-515/2013 S-270/2001
- Status last verified
- May 2024
- First submitted
- 30 Jul 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37507393Safi 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.
PubMed 37238744Safi 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.
PubMed 33255425
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Microenvironment in Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05982574
- Acronym / sponsor ID
- S-515/2013 S-270/2001
- Conditions
- Lung Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with completely resected lung adenocarcinoma stage IB and II
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- Second cancer within 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: From date of surgery until the date of death from any cause assessed up to 100 months
Association of tumor microenvironment with overall survival
1 secondary outcome
Recurrence-free survival
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Results publication: PubMed 37507393Beck 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.
- Results publication: PubMed 37238744Safi 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.
- Results publication: PubMed 33255425Safi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyer Safi, MD principal investigator
Technical University of Munich
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Adenocarcinoma, run by University Hospital Heidelberg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From date of surgery until the date of death from any cause assessed up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05982574, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024; AzTrials last refreshed its copy on 29 Oct 2026.