Table 2.
Detailed data specifications of the clinical and technical patient data collected for the MOMENTUM study.
| Information type | Example | Source | Time of accrual | Data elements and models | Terminology & ontology | ||
|---|---|---|---|---|---|---|---|
| OpenClinica | Classifier data |
Patient | Age, gender, comorbidities | HIS | Baseline | SDTM, CDASH, CDISC |
TNM-O, ISO 8601, EQ5D, NCI-Thesaurus, CTCAE, TG263-nomenclature, NAACCR |
| Disease | Stage, histology, biomarkers | HIS | Baseline | ||||
| Treatment | Chemotherapy, surgical intent, total RT dose | HIS | End of treatment | ||||
| Outcome data |
Toxicity | CTCAE | HIS | 3, 6, 12, 24 mos. post-RT | |||
| Cancer control and PROs | Local control, survival, QoL questionnaires |
HIS + patient |
3, 6, 12, 24 mos. post-RT |
||||
| Microsoft Azure | Diagnostic imaging data | Diagnostic CT, MR, PET imaging | PACS | End of treatment | DICOM-RT | Not applicable | |
| Radiotherapy planning data | Delineation/structure stets, planning CT | PACS, RIS | End of treatment | ||||
| Radiotherapy delivery data | Motion data files, machine log files, fractions | PACS, RIS | End of treatment | ||||
CDASH, clinical data acquisition standards harmonization; CDISC, clinical data interchange standards consortium; CRC, clinical research coordinator; CT, computerized tomography; CTCAE, common terminology criteria for adverse events; DICOM-RT, digital imaging and communications in medicine in radiation therapy; EQ-5D, standardized instrument for measuring generic health status; HIS, hospital information system; ISO 8601, data elements and interchange formats—information interchange—representation of dates an date and time; Mos, months; NAACR, North American association of central cancer registries; NCI thesaurus, National Cancer Institute's reference terminology and ontology; PACS, picture archiving and communication system; PET, positron emission tomography; PROs, patient reported outcomes; QoL questionnaires, quality of life questionnaires; RIS, radiology information system; RT, radiation therapy; SDTM, study data tabulation model; TG263 nomenclature, standardized nomenclature for radiation therapy; TNM-O, Ontology support for staging of malignant tumors.