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Using CDC Edits Metafile in the Registry to Support Clinical Trials Recruitment

Using CDC Edits Metafile in the Registry to Support Clinical Trials Recruitment. Alan R. Houser, MA, MPH C/NET Solutions Dennis Deapen, DrPH Los Angeles Cancer Surveillance Program. Finding a Clinical Trial. NCI web site, ClinicalTrials.gov , has 5933* open trials for cancer patients.

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Using CDC Edits Metafile in the Registry to Support Clinical Trials Recruitment

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  1. Using CDC Edits Metafile in the Registry to Support Clinical Trials Recruitment Alan R. Houser, MA, MPH C/NET Solutions Dennis Deapen, DrPH Los Angeles Cancer Surveillance Program

  2. Finding a Clinical Trial • NCI web site, ClinicalTrials.gov, has 5933* open trials for cancer patients. • Focused search tool to filter on disease, age, location, and treatment. * Checked on 2/21/2007

  3. ClinicalTrials.gov • Optimal for searching for available trials for a single patient or patients with similar characteristics. • Not suited for screening for trials for a large number of patients with dissimilar characteristics at one time.

  4. Another Approach:CDC Edits Tools (1) • Descriptive cancer terminology built in • Excellent at complex pattern matching • Readily customizable – each trial is translated into a single edit – edits can be removed from Metafile when closed to recruitment

  5. Another Approach: CDC Edits Tools (2) • Match multiple patients against multiple trials • Match hundreds of trials against large numbers of cases at one time • Portable – can distribute metafile widely

  6. ClinicalTrials.gov For each listed trial, three elements of eligibility criteria: • Disease characteristics • Patient characteristics • Prior concurrent therapy EDITS language can test each of these elements

  7. How to Write an Edit to Select a Trial • Identify inclusion and exclusion requirements for trial • Match requirements to data fields in registry data set • “Failing” an edit means “matching” a trial’s requirements – require failure to display message • “Missing data” – write edits to exclude cases that don’t match requirements, leaving cases that are still potential matches

  8. Demonstration Project (1) • Write metafile edits for a selection of actual clinical trials selected from ClinicalTrials.gov • Select trials that require a diagnosis of cancer – no prophylactic studies • Select trials (five for each site) that use data fields available in registry data

  9. Demonstration Project (2) • Match metafile edits against a sample of real cancer case reports from central registry (California Cancer Registry) • Select cases from 2004 forward to take advantage of Collaborative Staging

  10. Methodology • Datafile selected from California Cancer Registry Eureka database: NAACCR 11.1 format • Clinical Trials Metafile created with EditWriter 3.0: five trials for each site • Edits Metafile run against Eureka datafile with GenEdits Plus (beta)

  11. Selecting Trials fromClinicalTrials.Gov (1) Select by Primary Site and Location (California) • Breast Cancer • Total Trials = 789* • California Trials = 131* • Translated into Metafile Edits = 5 * Checked on 2/21/2007

  12. Selecting Trials fromClinicalTrials.Gov (2) Select by Primary Site and Location (California) • Prostate Cancer • Total Trials = 366* • California Trials = 70* • Translated into Metafile Edits = 5 * Checked on 2/21/2007

  13. Selecting Trials fromClinicalTrials.Gov (3) Select by Primary Site and Location (California) • Lung Cancer • Total Trials = 575* • California Trials = 107* • Translated into Metafile Edits = 5 * Checked on 2/21/2007

  14. Case Data File (1) Extract test file from California Cancer Registry’s Eureka database: • All patients diagnosed 2004-2006 (about 2.5 years) • Three sites: breast, prostate, lung • Vital status alive • Los Angeles County residents at diagnosis • 31,007 cases identified

  15. Case Data File (2) • Selected from California Cancer Registry’s Eureka database • 3 sites, patients alive at last contact: • Breast (C500-C509), 15,708 cases • Prostate (C619), 11,197 cases • Lung (C340-349), 4102 cases

  16. Tracing the Filtering Process (1) Breast Clinical Trial NCT00382070 • Start:31,007 cases • Exclude if not female, not alive • Step 1:19,588 cases • Exclude if not breast or if bilateral • Step 2:15,613 cases • Exclude if not invasive, not microscopically confirmed • Step 3:12,688 cases

  17. Tracing the Filtering Process (2) Breast Clinical Trial NCT00382070 • Exclude if not Stage I, II, IIIA • Step 4:10,870 cases • Exclude if ERA, PRA are within normal limits • Step 5:8430 cases • Exclude if hormone therapy not given • Step 6:867 cases • Exclude if not lumpectomy or simple mastectomy with lymph node staging • Final:756 cases

  18. Results: Five Breast Cancer Trials Total breast cases: 15,708 • NCT00074152: 11,302 (72%) • NCT00127205: 573 ( 3.6%) • NCT00382070: 756 ( 4.8%) • NCT00388726: 341 ( 2.2%) • NCT00390455: 1075 ( 6.8%)

  19. Results: Five Prostate Cancer Trials Total prostate cases: 11,197 • NCT00004124: 97 ( 0.9%) • NCT00063882: 9 ( 0.1%) • NCT00110214: 247 ( 2.2%) • NCT00123838: 2814 (25%) • NCT00402285: 12 ( 0.1%)

  20. Results: Five Lung Cancer Trials Total lung cases: 4102 • NCT00008385: 222 ( 5.4%) • NCT00268489: 948 (23%) • NCT00293332: 1682 (41%) • NCT00368992: 183 ( 4.5%) • NCT00409188 : 154 ( 3.8%)

  21. Summary • Metafile technology can be used to screen large data sets for potential clinical participants • Matching criteria is limited by registry data set • Additional criteria not available to registry may exclude patients identified by metafile matching

  22. Limitations of Metafile Scanningof Registry Data (1) • Data not collected • Her2/neu (except in California) • Date treatment ended • Clinical factors (lab tests, fitness)

  23. Limitations of Metafile Scanningof Registry Data (2) • Incomplete treatment data • Cases may be reported before treatment is completed • No identification of specific agents • No identification of multiple courses

  24. Limitations of Metafile Scanningof Registry Data (3) • Incomplete recurrence data • May not be available to central registry unless reported from hospital registries

  25. Extending the Technology:Hospital Registry • More timely identification of eligible cases • Monitor changes in patient status that could trigger eligibility (e.g., recurrence, additional treatment) • Notification of managing physician when patient become eligible • Interactive or batch processing • Data set not limited to state requirements

  26. Extending the Technology:Physician Reporting • Immediate notification of potential eligibility • Passive, not active, screening by physician or staff

  27. Thank You • Dennis Deapen (LA CSP), for guiding the direction of this work with his helpful suggestions • Mark Allen (CCR), for providing the data extract from the Eureka database • Winny Roshala (CCR), for help in translating clinical trial requirements into ICD-O-3 codes • Tom Rawson (CDC), for making available GenEdit Plus (beta) for running the edits

  28. For more information: Alan R. Houser C/NET Solutions 1936 University Ave, Suite 112 Berkeley CA 94704-1024 (510) 549-8914 alanh@askcnet.org

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