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Rapid Learning for Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01949259
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : September 30, 2016
Sponsor:
Collaborators:
Liverpool Cancer Therapy Centre
Macarthur Cancer Therapy Centre, Liverpool
Ingham Institute Hospital, Liverpool
NSW, Australia
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Study Description
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Brief Summary:
A retrospective, data mining project that re-uses routine patient care data for decision support systems.

Condition or disease
Lung Cancer

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
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Study Type : Observational
Actual Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Rapid Learning in Practice: A Lung Cancer Survival Decision Support System in Routine Patient Care Data
Study Start Date : September 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Group/Cohort
Retrospective collection
Retrospective collection of data from included lung cancer patients.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Local control [ Time Frame: From start of treatment until death, ]
    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.

  2. Distant metastases [ Time Frame: From treatment until end of study ]
    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).

  3. Dyspnea [ Time Frame: From inclusion until end of study ]
    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).

  4. Dysphagia [ Time Frame: From treatment until end of study ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Lung cancer patients
Criteria

Inclusion Criteria:

- Patients notes as suffering from lung cancer in at least one clinical data source.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949259


Locations
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Netherlands
MAASTRO clinic
Maastricht, Limburg, Netherlands, 6229 ET
Sponsors and Collaborators
Maastricht Radiation Oncology
Liverpool Cancer Therapy Centre
Macarthur Cancer Therapy Centre, Liverpool
Ingham Institute Hospital, Liverpool
NSW, Australia
Investigators
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Principal Investigator: Andre Dekker, Dr Maastro Clinic, The Netherlands
More Information
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Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01949259    
Other Study ID Numbers: Rapid learning lung cancer
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Keywords provided by Maastricht Radiation Oncology:
Retrospective
Lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases