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Clinical Decision Support -Clinical Trial Extension

Clinical trial discovery in the context of the oncology patient undergoing treatment for their primary tumor is time-consuming for the clinician and simply not often done in the community cancer care realm due to lack of knowledge of specific ongoing clinical trials in an automated way. In this scenario, the patient is referred by her primary care physician to an oncologist for an elevated CA 125 tumor marker. The 38-year-old female patient has a past history of breast cancer six years ago with no evidence of recurrence. She's recently had some abdominal distention which prompted a visit to her primary care physician. An ultrasound had been ordered showing some moderate fluid in the abdomen and pelvis and a solid and cystic mass in the right adnexa measuring 6.8 cm in maximal diameter. Surgical evaluation yields the finding of a stage IIIC epithelial ovarian mucinous cystadenocarcinoma.

The following is a summary of the steps:

• At the time of the referral, the primary care physician used the referral service and attached a CCD summary document of the patient's findings including her imaging study and tumor marker values. 
• This was incorporated into the electronic health record along with the assessment of the oncologist and his clinical staging. 
• The patient's consents were also registered in the electronic health record which included a consent for using her clinical de-identified data to query for a clinical trial match. 
• The record is transferred from the EHR to a an ECCF Knowledge service that evaluates the data against available clinical trials and returns matching trials for the individual patient.

Use case decompositions

• An ECCF service continually queries the clinical trials.gov site for up-to-date actively recruiting studies.
• A second ECCF service performs natural language processing and extracts the inclusion and exclusion criteria from the posted active clinical trials
• The electronic healthcare record abstracts a CCD summary that includes diagnoses, age, sex, and types of imaging studies as well as laboratory findings and submits the de-identified CCD to the knowledge management service within the ECCF.
• The knowledge management service develops a profile using the CCD to compare against known active clinical trials and publishes potential trials to the electronic health record.
• The electronic health record links the discovered clinical trials to the patient record based on a unique key and displays this information to the clinician when he accesses that patient's record.