Breast CancerNCT02362776
Metabolic Changes as a Diagnostic Indicator for Cancer
An observational study of Breast Cancer and Lung Cancer, run by Hasselt University at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Lung Cancer
- What is being tested?
- Venous blood sample
- How many people
- 426 participants
- Where
- 2 sitesBelgium
- Study dates
- Oct 2009to Jul 2012
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Diagnosis of breast or lung cancer
Who may be able to join
- Diagnosis of breast or lung cancer (new lesion)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Hasselt University
Hasselt, Limburg, 3500
About this study
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.
- Conditions
- Breast Cancer, Lung Cancer
- Being tested
- Venous blood sample
- Keywords
- NMR spectroscopy, metabolic changes, blood plasma, biomarker, cancer
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood sampleOther
Collection of a venous blood sample to investigate metabolic changes in blood
| Study group | Role | What they receive |
|---|---|---|
| breast cancer patients | Not described Receives: Other: Venous blood sample | |
| lung cancer patients | Not described Receives: Other: Venous blood sample | |
| control subjects | Not described Receives: Other: Venous blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic phenotype of cancer
Significant metabolic changes in blood between cancer patients \& control subjects
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startOct 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 426 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, Algemeen Ziekenhuis Vesalius, Ziekenhuis Maas en Kempen, Mariaziekenhuis Noord-Limburg
- Responsible party
- Principal investigator, Prof. dr. Michiel Thomeer, Hasselt University
- Investigators
- Michiel Thomeer, prof. dr., Principal investigator, Ziekenhuis Oost-LimburgKurt Baeten, dr., Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362776
- Sponsor's protocol ID
- 09/046U
- Status last verified
- Feb 2015
- First submitted
- 10 Dec 2013
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26487580
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Changes as a Diagnostic Indicator for Cancer
- ClinicalTrials.gov ID
- NCT02362776
- Acronym / sponsor ID
- 09/046U
- Conditions
- Breast Cancer, Lung Cancer
- Keywords
- NMR spectroscopy, metabolic changes, blood plasma, biomarker, cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, Algemeen Ziekenhuis Vesalius, Ziekenhuis Maas en Kempen, Mariaziekenhuis Noord-Limburg
- Study start
- Oct 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| breast cancer patients | – | Other: Venous blood sample |
| lung cancer patients | – | Other: Venous blood sample |
| control subjects | – | Other: Venous blood sample |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diagnosis of breast or lung cancer
Key inclusion criteria (1 listed)
- Diagnosis of breast or lung cancer (new lesion)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous blood sampleCollection of a venous blood sample to investigate metabolic changes in blood | Other | breast cancer patients, control subjects, lung cancer patients |
Primary outcome
Metabolic phenotype of cancer
Time frame: day 1
Significant metabolic changes in blood between cancer patients \& control subjects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
- Derived from this study: PubMed 26487580Louis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michiel Thomeer, prof. dr. principal investigator
Ziekenhuis Oost-Limburg
Kurt Baeten, dr. principal investigator
Hasselt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Lung Cancer, run by Hasselt University at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic phenotype of cancer (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02362776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2015.