- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02362776
Metabolic Changes as a Diagnostic Indicator for Cancer
February 9, 2015 updated by: Prof. dr. Michiel Thomeer, Hasselt University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
426
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
-
-
Limburg
-
Genk, Limburg, Belgium, 3600
- Ziekenhuis Oost-Limburg
-
Hasselt, Limburg, Belgium, 3500
- Hasselt University
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Diagnosis of breast or lung cancer
Description
Inclusion Criteria:
- Diagnosis of breast or lung cancer (new lesion)
Exclusion Criteria:
- 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
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 |
Intervention / Treatment |
---|---|
control subjects
|
Collection of a venous blood sample to investigate metabolic changes in blood
|
lung cancer patients
|
Collection of a venous blood sample to investigate metabolic changes in blood
|
breast cancer patients
|
Collection of a venous blood sample to investigate metabolic changes in blood
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic phenotype of cancer
Time Frame: day 1
|
Significant metabolic changes in blood between cancer patients & control subjects
|
day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michiel Thomeer, prof. dr., Ziekenhuis Oost-Limburg
- Principal Investigator: Kurt Baeten, dr., Hasselt University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
October 1, 2009
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
December 10, 2013
First Submitted That Met QC Criteria
February 9, 2015
First Posted (Estimate)
February 13, 2015
Study Record Updates
Last Update Posted (Estimate)
February 13, 2015
Last Update Submitted That Met QC Criteria
February 9, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 09/046U
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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