NCT02484872

Brief 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 leading to ICU admission and the risk of death.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

7.6 years

First QC Date

June 24, 2015

Last Update Submit

August 20, 2021

Conditions

Lung Neoplasms

Keywords

InflammationGlasgow scoreIntensive Care UnitEmergency

Outcome Measures

Primary Outcomes (1)

  • Survival

    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

    From inclusion until death, or a least 48 months

Study Arms (1)

Lung neoplasms

Lung neoplasms irrespective of stage and histology

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Newly diagnosed untreated lung neoplasms

You may qualify if:

  • Lung neoplasms irrespective of stage, histology

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

Brussels, 1000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sampling (serum)

MeSH Terms

Conditions

Lung NeoplasmsInflammationEmergencies

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Anne-Pascale Meert, MD, PhD

    Jules Bordet Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2015

First Posted

June 30, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

August 23, 2021

Record last verified: 2021-08

Locations

BE(1)