Lung CancerIRLCNCT01955343
Immune Response in Lung Cancer
An observational study of Lung Cancer, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer
- How many people
- 100 participants
- Where
- 1 siteLithuania
- Study dates
- Sep 2012to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lung Cancer
- Keywords
- Immune response, Cancer
- Medical subject headings
- Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: one year after enrolment to the study
Secondary outcomes (1)
overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startSep 2012
- Primary completionJul 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marius Zemaitis, Lithuanian University of Health Sciences
- Investigators
- Marius Zemaitis, Assoc.Prof., Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955343
- Sponsor's protocol ID
- IRLC-1109
- Acronym
- IRLC
- Status last verified
- Jun 2017
- First submitted
- 27 Sep 2013
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jackute J, Zemaitis M, Pranys D, Sitkauskiene B, Miliauskas S, Vaitkiene S, Sakalauskas R. Distribution of M1 and M2 macrophages in tumor islets and stroma in relation to prognosis of non-small cell lung cancer. BMC Immunol. 2018 Jan 24;19(1):3. doi: 10.1186/s12865-018-0241-4.
PubMed 29361917
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response in Lung Cancer
- ClinicalTrials.gov ID
- NCT01955343
- Acronym / sponsor ID
- IRLC / IRLC-1109
- Conditions
- Lung Cancer
- Keywords
- Immune response, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Oct 2013 (estimated)
- 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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
progression-free survival
Time frame: one year after enrolment to the study
1 secondary outcome
overall survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Derived from this study: PubMed 29361917Jackute J, Zemaitis M, Pranys D, Sitkauskiene B, Miliauskas S, Vaitkiene S, Sakalauskas R. Distribution of M1 and M2 macrophages in tumor islets and stroma in relation to prognosis of non-small cell lung cancer. BMC Immunol. 2018 Jan 24;19(1):3. doi: 10.1186/s12865-018-0241-4.
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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.
Marius Zemaitis, Assoc.Prof. principal investigator
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
progression-free survival (time frame: one year after enrolment to the study). 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 NCT01955343, which also lists 1 linked publication.
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 23 Jun 2017.