NCT02362776

Brief Summary

This study aims to determine whether metabolic changes occur in blood plasma of cancer patients, and whether these changes can be used as a biomarker to detect cancer. These analyses will be done by means of nuclear magnetic resonance (NMR) spectroscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
426

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2013

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

Enrollment Period

2.8 years

First QC Date

December 10, 2013

Last Update Submit

February 9, 2015

Conditions

Keywords

NMR spectroscopymetabolic changesblood plasmabiomarkercancer

Outcome Measures

Primary Outcomes (1)

  • Metabolic phenotype of cancer

    Significant metabolic changes in blood between cancer patients \& control subjects

    day 1

Study Arms (3)

breast cancer patients

Other: Venous blood sample

lung cancer patients

Other: Venous blood sample

control subjects

Other: Venous blood sample

Interventions

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

breast cancer patientscontrol subjectslung cancer patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diagnosis of breast or lung cancer

You may qualify if:

  • Diagnosis of breast or lung cancer (new lesion)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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, Vanhove K, Vandeurzen K, Darquennes K, Vansteenkiste J, Dooms C, de Jonge E, Thomeer M, Mesotten L. Metabolic phenotyping of human blood plasma: a powerful tool to discriminate between cancer types? Ann Oncol. 2016 Jan;27(1):178-84. doi: 10.1093/annonc/mdv499. Epub 2015 Oct 20.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Metabolic phenotype of cancer

MeSH Terms

Conditions

Breast NeoplasmsLung NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Michiel Thomeer, prof. dr.

    Ziekenhuis Oost-Limburg

    PRINCIPAL INVESTIGATOR
  • Kurt Baeten, dr.

    Hasselt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

December 10, 2013

First Posted

February 13, 2015

Study Start

October 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

February 13, 2015

Record last verified: 2015-02

Locations