Immune Response in Lung Cancer (IRLC)
June 22, 2017 updated by: Marius Zemaitis, Lithuanian University of Health Sciences
This study is designed to evaluate the importance of the immune cells localization (distribution) between malignant tumor islets and surrounding stroma and to investigate the associations between these immune cells as well as cytokines and clinicopathological and prognostic factors of non-small cell lung cancer (NSCLC) patients.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaunas, Lithuania, LT 44307
- Lithuanian University of Health Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Lithuanian residents who are investigated ant treated in Hospital of Lithuanian University of Health Sciences Kaunas Clinics Department of Pulmonology and Immunology and Department of Heart, thoracic and vascular surgery
Description
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) score of 0-1
- Patients with histologically documented non-small cell lung cancer
- Control group - patients without non-small cell lung cancer
- Written (signed) Informed Consent to participate in the study
Exclusion Criteria:
- Any other malignancies within 5 years
- Any unstable systemic disease (including active infections, significant cardiovascular disease)
- Prior chemotherapy or radiotherapy
- Autoimmune disease
- Nursing or pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Lung cancer
Newly diagnosed and untreated non small cell lung cancer patients who underwent surgical resection for NSCLC (pathological stage I-III)
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Control
Subjects who will have surgery due to recurrent spontaneous pneumothorax Patients without lung cancer or other malignancies
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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progression-free survival
Time Frame: one year after enrolment to the study
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one year after enrolment to the study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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overall survival
Time Frame: 3 years
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marius Zemaitis, Assoc.Prof., Lithuanian University of Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
September 27, 2013
First Submitted That Met QC Criteria
September 27, 2013
First Posted (Estimate)
October 7, 2013
Study Record Updates
Last Update Posted (Actual)
June 23, 2017
Last Update Submitted That Met QC Criteria
June 22, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRLC-1109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.