Lung CancerNCT01949259
Rapid Learning for Lung Cancer
An observational study of Lung Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
A retrospective, data mining project that re-uses routine patient care data for decision support systems. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- How many people
- 10,000 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2013to Aug 2014
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Lung cancer patients
Who may be able to join
- Patients notes as suffering from lung cancer in at least one clinical data source.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Learning in Practice: A Lung Cancer Survival Decision Support System in Routine Patient Care Data
A retrospective, data mining project that re-uses routine patient care data for decision support systems.
Read the detailed description
By installing tools that extract clinical data from electronic health records and image data from the Picture Archiving and Communication System, decision support systems are built and validated that can predict survival and treatment toxicities of lung cancer patients treated with radiotherapy.
- Conditions
- Lung Cancer
- Keywords
- Retrospective, Lung cancer
- Medical subject headings
- Lung Neoplasms
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 |
|---|---|---|
| Retrospective collection | Retrospective collection of data from included lung cancer patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Retrospective data will be collected from each included patient from start of radiotherapy until end of study or death (an expected average of 10 years).
Measured: From radiotherapy until death
Secondary outcomes (4)
Local control
Data will be collected from inclusion in the study until end of study of death (an expected average time frame of 10 years) concerning the local control of this tumour.
Measured: From start of treatment until death,
Distant metastases
Data concerning the possible occurence of distant metastases will be collected from each patient from inclusion until end of study or date of death (an expected average time frame of 10 years).
Measured: From treatment until end of study
Dyspnea
From each included patient, dyspnea scores will be collected from start of treatment until end of study or date of death (an expected average time frame of 10 years).
Measured: From inclusion until end of study
Dysphagia
Dysphagia scores will be collected from each participating patient from treatment until end of study or date of death (an average time frame of 10 years)
Measured: From treatment until end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool Cancer Therapy Centre, Macarthur Cancer Therapy Centre, Liverpool, Ingham Institute Hospital, Liverpool, NSW, Australia
- Responsible party
- Sponsor
- Investigators
- Andre Dekker, Dr, Principal investigator, Maastro Clinic, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949259
- Sponsor's protocol ID
- Rapid learning lung cancer
- Status last verified
- Sep 2016
- First submitted
- 10 Sep 2013
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Learning in Practice: A Lung Cancer Survival Decision Support System in Routine Patient Care Data
- ClinicalTrials.gov ID
- NCT01949259
- Acronym / sponsor ID
- Rapid learning lung cancer
- Conditions
- Lung Cancer
- Keywords
- Retrospective, Lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- Liverpool Cancer Therapy Centre, Macarthur Cancer Therapy Centre, Liverpool, Ingham Institute Hospital, Liverpool, NSW, Australia
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Sep 2013 (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.
A retrospective, data mining project that re-uses routine patient care data for decision support systems.
Detailed description
By installing tools that extract clinical data from electronic health records and image data from the Picture Archiving and Communication System, decision support systems are built and validated that can predict survival and treatment toxicities of lung cancer patients treated with radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective collection | – | –Retrospective collection of data from included lung cancer patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Lung cancer patients
Key inclusion criteria (1 listed)
- Patients notes as suffering from lung cancer in at least one clinical data source.
Key exclusion criteria (0 listed)
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
Survival
Time frame: From radiotherapy until death
Retrospective data will be collected from each included patient from start of radiotherapy until end of study or death (an expected average of 10 years).
4 secondary outcomes
Local control
Time frame: From start of treatment until death,
Distant metastases
Time frame: From treatment until end of study
Dyspnea
Time frame: From inclusion until end of study
Dysphagia
Time frame: From treatment until end of study
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 30 Sep 2016.
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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.
Andre Dekker, Dr principal investigator
Maastro Clinic, The Netherlands
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 Lung Cancer, run by Maastricht Radiation Oncology 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 0 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 30 Sep 2016. 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?
Survival (time frame: From radiotherapy until death). 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 30 Sep 2016.