Has Inflammation a Significant Implication in Lung Cancer Evolution?

August 20, 2021 updated by: European Lung Cancer Working Party

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

400

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

  • Belgium
      • Brussels, Belgium, 1000
        • Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newly diagnosed untreated lung neoplasms

Description

Inclusion Criteria:

  • Lung neoplasms irrespective of stage, histology

Exclusion Criteria:

  • 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)

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 neoplasms
Lung neoplasms irrespective of stage and histology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: Measured from diagnosis until death or last date known to be alive, or at least 48 months
Measured from diagnosis until death or last date known to be alive, or at least 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications leading to emergency/ICU
Time Frame: From inclusion until death, or a least 48 months
Recording any complication leading to consultation at the emergency department or admission into the intensive care unit
From inclusion until death, or a least 48 months

Collaborators and Investigators

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

Sponsor

European Lung Cancer Working Party

Collaborators

Jules Bordet Institute

Investigators

  • Study Chair: Anne-Pascale Meert, MD, PhD, Jules Bordet Institute

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 (Actual)

May 1, 2015

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Actual)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELCWP01501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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