Metabolic Changes as a Diagnostic Indicator for Cancer | NCT02362776

Studies
Metabolic Changes as a Diagnostic Indicator for Cancer

NCT02362776

Sponsor

Hasselt University

Status

Completed

Last Update Posted

Feb 13, 2015Estimated

Enrollment

426Actual

Phase

Not provided

Conditions

Breast Cancer
Lung Cancer

Interventions

Venous blood sample

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Dec 10, 2013

First Submission Date that Met QC Criteria

Feb 9, 2015

First Posted Date

Feb 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2015

Last Update Posted Date

Feb 13, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. dr. Michiel Thomeer, prof. dr., Hasselt UniversityPrincipal Investigator

Lead Sponsor

Hasselt UniversityOTHER

Collaborators

Name	Class
Ziekenhuis Oost-Limburg	OTHER
Algemeen Ziekenhuis Vesalius	OTHER
Ziekenhuis Maas en Kempen	OTHER
Mariaziekenhuis Noord-Limburg

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

426Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
breast cancer patients			Other: Venous blood sample
lung cancer patients			Other: Venous blood sample
control subjects			Other: Venous blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Venous blood sample	Other	Collection of a venous blood sample to investigate metabolic changes in blood	breast cancer patients control subjects lung cancer patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Metabolic phenotype of cancer	Significant metabolic changes in blood between cancer patients & control subjects	day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Diagnosis of breast or lung cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michiel Thomeer, prof. dr.	Ziekenhuis Oost-Limburg	Principal Investigator
Kurt Baeten, dr.	Hasselt University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ziekenhuis Oost-Limburg		Genk	Limburg	3600	Belgium
Hasselt University

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26487580	Derived	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.

ID	Term
D001943	Breast Neoplasms
D008175	Lung Neoplasms
D009369	Neoplasms

ID	Term
D009371	Neoplasms by Site
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases