CancerNCT00956878
Cancer Pain Single Nucleotide Polymorphisms (SNPs)
An observational study of Cancer and Pain, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Cancer pain is common in advanced cancer patients. Opioids are the mainstay of treatment in cancer pain. Responsiveness to and tolerability of opioids is, amongst others, determined by small variations in human DNA. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 243 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2008to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer pain patients in a large university hospital
Who may be able to join
- Cancer pain patients
Who cannot join
- Patients not able to provide informed consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus MC, Centrumlocatie en Daniel den Hoed
Rotterdam, South Holland, 3000CA
About this study
Official title: Storage and Analysis of Patient Blood-samples for Cancer Pain Research
Cancer pain is common in advanced cancer patients. Opioids are the mainstay of treatment in cancer pain. Responsiveness to and tolerability of opioids is, amongst others, determined by small variations in human DNA. Using blood samples from clinically well-defined cancer pain patients, the investigators are going to analyze single nucleotide polymorphisms (SNPs) in genes that are known to be involved in responsiveness to opioids and sensitivity to pain.
- Keywords
- Cancer, Pain, SNP
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer Pain Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between pain SNPs and equianalgesic opioid requirement
candidate SNP analysis
Measured: timepoint at blood sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joost LM Jongen, Erasmus Medical Center
- Investigators
- Joost L Jongen, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956878
- Sponsor's protocol ID
- MEC2008-166
- Status last verified
- Dec 2014
- First submitted
- 10 Aug 2009
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Storage and Analysis of Patient Blood-samples for Cancer Pain Research
- ClinicalTrials.gov ID
- NCT00956878
- Acronym / sponsor ID
- MEC2008-166
- Keywords
- Cancer, Pain, SNP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Aug 2009 (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.
Cancer pain is common in advanced cancer patients. Opioids are the mainstay of treatment in cancer pain. Responsiveness to and tolerability of opioids is, amongst others, determined by small variations in human DNA. Using blood samples from clinically well-defined cancer pain patients, the investigators are going to analyze single nucleotide polymorphisms (SNPs) in genes that are known to be involved in responsiveness to opioids and sensitivity to pain.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer Pain Patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer pain patients in a large university hospital
Key inclusion criteria (1 listed)
- Cancer pain patients
Key exclusion criteria (1 listed)
- Patients not able to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation between pain SNPs and equianalgesic opioid requirement
Time frame: timepoint at blood sample
candidate SNP analysis
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 24 Dec 2014.
- Related InfoLink provided by the sponsor.
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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.
Joost L Jongen, MD PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Pain, run by Erasmus Medical Center at 1 site in Netherlands.
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 1 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 24 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
correlation between pain SNPs and equianalgesic opioid requirement (time frame: timepoint at blood sample). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2014.