LC-NMR Study Biomarkers to Detect Lung Cancer

NCT02024113 | Completed

• 1 other identifier: 12/081U
• Study Type: observational
• Target: 646
• Locations: 1 country
• Sites: 2

Brief Summary

Lung cancer is the most common cancer in men and the fourth most common cancer in women worldwide. Until today no effective method permits the early detection of lung cancer. Consequently, lung cancer is often diagnosed owing to symptoms of advanced disease. To address this problem, detection methods with an improved sensitivity and specificity are urgently needed. Over the past decade, accumulating evidence shows that the metabolism of cancer cells differs from that of normal cells. More specifically, the entire metabolism of cancer cells is reorganized or reprogrammed to increase anabolic reactions that induce cell growth and survival. Metabolic reprogramming during the development of cancer is driven by aberrant signaling pathways due to the activation of oncogenes and the loss of tumor suppressor genes. Furthermore, the microenvironment of the tumor plays a role in metabolic reprogramming. The altered cancer metabolism is characterized by an increased glycolysis, the production of lactate and the biosynthesis of macromolecules, such as proteins, lipids and nucleotides. Cancer cells have a high glycolytic rate and eliminate most of the glucose-derived carbon as lactate rather than oxidizing it completely via oxidative phosphorylation, a phenomenon known as the Warburg effect. The breakdown of glucose and other nutrients leads to a high energy production and provides the Krebs cycle with intermediates, which consequently are allocated to metabolic pathways that support biosynthesis. Metabolites are the end products of cellular metabolism and are therefore closely related to the observed phenotype. Disturbances in biochemical pathways which occur during the development of cancer consequently provoke changes in the metabolic phenotype. As a result, low-molecular weight metabolites are very attractive biomarkers for different cancer types. Nuclear magnetic resonance (NMR) spectroscopy enables the identification and quantitative analysis of complex mixtures of metabolites, as in plasma and serum, without an extended sample preparation. The present study aims to determine the metabolic phenotype of lung cancer by means of proton (1H)-NMR spectroscopy. Once the phenotype determined (training cohort), this has to be validated by an independent cohort.

Conditions

Lung Cancer

Keywords

validation; model; metabolic profile; positron emission tomography

Outcome Measures

Primary Outcomes (1)

• Metabolic phenotype of lung cancer

  Plasma: metabolic phenotype by NMR spectroscopy

  day1

Secondary Outcomes (4)

• Overall survival

  the entire duration of the study

• Progression-free survival

  the entire duration of the studie

• Histology

  once

• Stage

  once

Study Arms (2)

Lung cancer

Subjects with lung cancer detected by a computed tomography (CT)-scan and referred to a positron emission tomography (PET)/CT-scan are included. The diagnosis of lung cancer is confirmed by means of an pathological biopsy or by a medical doctor specialized in oncology with respect to radiological or clinical data. Intervention: a fasted venous blood sample is taken before PET-scan

Other: Venous blood sample

Control subjects

The control group consists of subjects who were referred to the department Nuclear Medicine for an examination of the heart. This control group represents the average population, consists of healthy subjects and patients with non-cancer diseases and who did not undergo a PET/CT-scan. Intervention: fasted venous blood sample

Other: Venous blood sample

Interventions

Venous blood sample OTHER

Collection of a venous blood sample to investigate metabolic changes in blood

Control subjects; Lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population: patients with a new diagnosis of lung cancer Control population: matched subjects with no diagnosis of cancer

You may qualify if:

• Diagnosis of a new lesion in the lung

You may not qualify if:

• a prior diagnosis of cancer in the past
• Not fasted for at least 6 hours
• Plasma glucose concentration ≥ 200 mg/dl
• Intake of medication at the day of investigation
• History/treatment of cancer in the previous 5 years

Sponsors & Collaborators

• Hasselt University: lead
• Ziekenhuis Oost-Limburg: collaborator
• Algemeen Ziekenhuis Vesalius: collaborator
• Ziekenhuis Maas en Kempen: collaborator
• Mariaziekenhuis Noord-Limburg: collaborator

Study Sites (2)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Hasselt University

Hasselt, Limburg, 3500, Belgium

Location

Related Publications (1)

• Louis E, Adriaensens P, Guedens W, Bigirumurame T, Baeten K, Vanhove K, Vandeurzen K, Darquennes K, Vansteenkiste J, Dooms C, Shkedy Z, Mesotten L, Thomeer M. Detection of Lung Cancer through Metabolic Changes Measured in Blood Plasma. J Thorac Oncol. 2016 Apr;11(4):516-23. doi: 10.1016/j.jtho.2016.01.011. Epub 2016 Feb 29.

  PMID: 26949046 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma is used to determine the metabolic profile by NMR spectroscopy

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michiel J Thomeer, MD, PhD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 31, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

BE (2)