Rapid Learning for Lung Cancer

Lung Cancer Clinical Trial

Official title:

Rapid Learning in Practice: A Lung Cancer Survival Decision Support System in Routine Patient Care Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949259
• Other study ID #: Rapid learning lung cancer
• Status: Completed
• Phase: N/A
• First received: September 10, 2013
• Last updated: September 29, 2016
• Start date: September 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2016
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

A retrospective, data mining project that re-uses routine patient care data for decision support systems.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Netherlands	MAASTRO clinic	Maastricht	Limburg

Sponsors (5)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology	Ingham Institute Hospital, Liverpool, Liverpool Cancer Therapy Centre, Macarthur Cancer Therapy Centre, Liverpool, NSW, Australia

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	From radiotherapy until death	No
Secondary	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.	From start of treatment until death,	No
Secondary	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).	From treatment until end of study	No
Secondary	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).	From inclusion until end of study	No
Secondary	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)	From treatment until end of study	No