Lung NeoplasmsNCT02484872
Has Inflammation a Significant Implication in Lung Cancer Evolution?
An observational study of Lung Neoplasms, run by European Lung Cancer Working Party at 1 site in Belgium.
Trial summary
Systemic inflammation is a potential prognostic factor in cancer. Inflammation scores as the Glasgow score have been tested in cancer and specifically in lung cancer patients. The aim of the study is to look at the prognostic and predictive value of inflammation during cancer evolution, on the risk of complications… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- How many people
- 400 participants
- Where
- 1 siteBelgium
- Study dates
- May 2015to Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed untreated lung neoplasms
Who may be able to join
- Lung neoplasms irrespective of stage, histology
Who cannot join
- Previously treated lung neoplasms
- A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval)
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, 1000
About this study
Official title: L'Inflammation A-t-elle Une Implication Significative Dans l'évolution du Cancer Bronchique?
Systemic inflammation is a potential prognostic factor in cancer. Inflammation scores as the Glasgow score have been tested in cancer and specifically in lung cancer patients. The aim of the study is to look at the prognostic and predictive value of inflammation during cancer evolution, on the risk of complications leading to ICU admission and the risk of death.
Read the detailed description
Patients with newly diagnosed lung cancer will be eligible. All patients will have a blood sampling allowing testing inflammation and cytokine analyses at diagnosis, during work-up and in case of complication.
- Conditions
- Lung Neoplasms
- Keywords
- Inflammation, Glasgow score, Intensive Care Unit, Emergency
- Medical subject headings
- Lung Neoplasms, Inflammation, Emergencies
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 neoplasms | Lung neoplasms irrespective of stage and histology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: Measured from diagnosis until death or last date known to be alive, or at least 48 months
Secondary outcomes (1)
Complications leading to emergency/ICU
Recording any complication leading to consultation at the emergency department or admission into the intensive care unit
Measured: From inclusion until death, or a least 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Lung Cancer Working Party
- Sponsor type
- University, hospital or other
- Collaborators
- Jules Bordet Institute
- Responsible party
- Sponsor
- Investigators
- Anne-Pascale Meert, MD, PhD, Study chair, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484872
- Sponsor's protocol ID
- ELCWP01501
- Status last verified
- Aug 2021
- First submitted
- 24 Jun 2015
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L'Inflammation A-t-elle Une Implication Significative Dans l'évolution du Cancer Bronchique?
- ClinicalTrials.gov ID
- NCT02484872
- Acronym / sponsor ID
- ELCWP01501
- Conditions
- Lung Neoplasms
- Keywords
- Inflammation, Glasgow score, Intensive Care Unit, Emergency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- European Lung Cancer Working PartyUniversity, hospital or other
- Collaborators
- Jules Bordet Institute
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 Jun 2015 (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.
Systemic inflammation is a potential prognostic factor in cancer. Inflammation scores as the Glasgow score have been tested in cancer and specifically in lung cancer patients. The aim of the study is to look at the prognostic and predictive value of inflammation during cancer evolution, on the risk of complications leading to ICU admission and the risk of death.
Detailed description
Patients with newly diagnosed lung cancer will be eligible. All patients will have a blood sampling allowing testing inflammation and cytokine analyses at diagnosis, during work-up and in case of complication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung neoplasms | – | –Lung neoplasms irrespective of stage and histology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed untreated lung neoplasms
Key inclusion criteria (1 listed)
- Lung neoplasms irrespective of stage, histology
Key exclusion criteria (2 listed)
- Previously treated lung neoplasms
- A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval)
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
Survival
Time frame: Measured from diagnosis until death or last date known to be alive, or at least 48 months
1 secondary outcome
Complications leading to emergency/ICU
Time frame: From inclusion until death, or a least 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Anne-Pascale Meert, MD, PhD study chair
Jules Bordet Institute
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 Neoplasms, run by European Lung Cancer Working Party at 1 site in Belgium.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Aug 2021. 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 Belgium. 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?
Results are not available in the source record.
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?
Survival (time frame: Measured from diagnosis until death or last date known to be alive, or at least 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2021; AzTrials last refreshed its copy on 27 Oct 2026.