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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

Tracking Information
First Submitted Date September 10, 2013
First Posted Date September 24, 2013
Last Update Posted Date September 30, 2016
Study Start Date September 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 19, 2013)		 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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 19, 2013)
  • 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.
  • 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).
  • 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).
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rapid Learning for Lung Cancer
Official Title Rapid Learning in Practice: A Lung Cancer Survival Decision Support System in Routine Patient Care Data
Brief Summary 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Lung cancer patients
Condition Lung Cancer
Intervention Not Provided
Study Groups/Cohorts Retrospective collection
Retrospective collection of data from included lung cancer patients.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 19, 2013)		 10000
Original Estimated Enrollment Same as current
Actual Study Completion Date August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

- Patients notes as suffering from lung cancer in at least one clinical data source.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT01949259
Other Study ID Numbers Rapid learning lung cancer
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Maastricht Radiation Oncology
Original Responsible Party Same as current
Current Study Sponsor Maastricht Radiation Oncology
Original Study Sponsor Same as current
Collaborators
  • Liverpool Cancer Therapy Centre
  • Macarthur Cancer Therapy Centre, Liverpool
  • Ingham Institute Hospital, Liverpool
  • NSW, Australia
Investigators
Principal Investigator: Andre Dekker, Dr Maastro Clinic, The Netherlands
PRS Account Maastricht Radiation Oncology
Verification Date September 2016