Lung CancerNCT01274858
Sensory Mapping and Thermal Thresholds After Thoracic Surgery
An observational study of Lung Cancer, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
The study will investigate topography of sensory changes late after lung cancer surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 12 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2011to Apr 2011
- 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: Lung cancer patients
Who may be able to join
- Understand Danish
- Age > 18 years old
- PTPS
Who cannot join
- Cognitive dysfunction
- Repeated thoracic surgery
- Nerve injury from other causes
- Drug or alcohol abuse
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Rigshospitalet
Copenhagen, 2100
Section for Surgical Pathophysiology 4074
Copenhagen, 2100
About this study
The study will investigate topography of sensory changes late after lung cancer surgery
- Conditions
- Lung Cancer
- Keywords
- persistent pain, neuropathic pain, Thoracotomy, Chronic Pain
- Medical subject headings
- Lung Neoplasms, Neuralgia, Chronic 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 |
|---|---|---|
| lung cancer surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal thresholds (Quantitative Sensory Testing [QST])
Two QST with 10 days interval
Measured: average 18 months after surgery
Sensory mapping
Two QST with 10 days interval
Measured: average 18 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2011
- Study completionApr 2011
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 Lung CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274858
- Sponsor's protocol ID
- H-B-2008-059/6
- Status last verified
- Feb 2011
- First submitted
- 10 Jan 2011
- Last updated
- 28 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Werner MU, Ringsted TK, Kehlet H, Wildgaard K. Sensory testing in patients with postthoracotomy pain syndrome: Part 1: mirror-image sensory dysfunction. Clin J Pain. 2013 Sep;29(9):775-83. doi: 10.1097/AJP.0b013e318277b646.
PubMed 23328340
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Mapping and Thermal Thresholds After Thoracic Surgery
- ClinicalTrials.gov ID
- NCT01274858
- Acronym / sponsor ID
- H-B-2008-059/6
- Conditions
- Lung Cancer
- Keywords
- persistent pain, neuropathic pain, Thoracotomy, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 12 Jan 2011 (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.
The study will investigate topography of sensory changes late after lung cancer surgery
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung cancer surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients
Key inclusion criteria (3 listed)
- Understand Danish
- Age > 18 years old
- PTPS
Key exclusion criteria (4 listed)
- Cognitive dysfunction
- Repeated thoracic surgery
- Nerve injury from other causes
- Drug or alcohol abuse
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
Thermal thresholds (Quantitative Sensory Testing [QST])
Time frame: average 18 months after surgery
Two QST with 10 days interval
Sensory mapping
Time frame: average 18 months after surgery
Two QST with 10 days interval
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 28 Sep 2011.
- Derived from this study: PubMed 23328340Werner MU, Ringsted TK, Kehlet H, Wildgaard K. Sensory testing in patients with postthoracotomy pain syndrome: Part 1: mirror-image sensory dysfunction. Clin J Pain. 2013 Sep;29(9):775-83. doi: 10.1097/AJP.0b013e318277b646.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Cancer, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
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 3 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 28 Sep 2011. 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 Denmark. 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?
Thermal thresholds (Quantitative Sensory Testing [QST]) (time frame: average 18 months after surgery). The study lists 2 primary outcomes in all. 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 NCT01274858, 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 28 Sep 2011.