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

  • Lithuania
      • Kaunas, Lithuania, LT 44307
        • Lithuanian University of Health Sciences

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
Lung cancer
Newly diagnosed and untreated non small cell lung cancer patients who underwent surgical resection for NSCLC (pathological stage I-III)
Control
Subjects who will have surgery due to recurrent spontaneous pneumothorax Patients without lung cancer or other malignancies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: one year after enrolment to the study
one year after enrolment to the study

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lithuanian University of Health Sciences

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.

General Publications

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.

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