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NCT02362776 Clinical Trial

Metabolic Changes as a Diagnostic Indicator for Cancer

Breast Cancer Clinical Trial

Official title:
Metabolic Changes as a Diagnostic Indicator for Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02362776
Other study ID # 09/046U
Secondary ID
Status Completed
Phase N/A
First received December 10, 2013
Last updated February 9, 2015
Start date October 2009
Est. completion date July 2012

Study information
Verified date February 2015
Source Hasselt University
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 426
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Other:
• Venous blood sample
Collection of a venous blood sample to investigate metabolic changes in blood

Locations
Country Name City State
Belgium Ziekenhuis Oost-Limburg Genk Limburg
Belgium Hasselt University Hasselt Limburg

Sponsors (5)
Lead Sponsor Collaborator
Hasselt University Algemeen Ziekenhuis Vesalius, Mariaziekenhuis Noord-Limburg, Ziekenhuis Maas en Kempen, Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Metabolic phenotype of cancer Significant metabolic changes in blood between cancer patients & control subjects day 1 No
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