Table 1.

Types of RWD from medical and research records for APOLLO

Captured into smart electronic clinical reporting and XML forms with data dictionaries, valid value requirements, logging features, and business rules. Data elements are labeled with a unique coded APOLLO ID participant identifier.

Baseline data: Registration, eligibility, consent, demographics, height, weight, risk factors, smoking status, marital status, type of insurance, medical history, medications, supplements, reproductive history, and family cancer history.

Surgical treatment: Surgical date, surgical procedures performed, AJCC stage with edition details, and disease site–specific surgical findings, including primary tumor size, disease distribution (location and size pre/post surgery), residual disease status, military disease, laterality, margins, redacted operative report(s), and comments.

Pathologic findings: Diagnosis date, definitive surgery date, ICD site and behavior codes, detailed College of American Pathology electronic cancer checklist13 with harmonized data dictionaries and conversion between versions, redacted pathology reports, including cytologic findings, clinical biomarker assessments, and other findings.

Case‐level data: Case organ type, lesion type, malignancy type, primary site of diagnosis, ICD‐10 code, histology code, TNM edition number, pathological group stage at diagnosis, CAP organ data creation status, and biomarker creation status.

Research pathology characterization: Baseline and in‐depth research pathology characterization will be provided and compared with the clinical diagnosis for tumor samples by expert pathologists and tissue imaging researchers. The types of annotation may include tissue composition details, clinical biomarker staining, and computer‐generated annotation in imaged slides with intact tumor tissues or tissues before and after laser microdissection.

Molecular data: Including redacted report, primary findings, and secondary findings when applicable from CLIA testing, clinical recommendations, clinical actions taken and outcomes, and XML data from CLIA assays when available implementing best practices and guidelines from the College of American Pathology, American Society of Clinical Oncology, National Comprehensive Cancer Network, and American College of Genetics and Genomic for risk assessments, interpretation, certification, and genetic counseling health conditions, including cancer.

DoD uses the Illumina TruSight Tumor 15 tumor profiling assay with plans to deploy the TruSight Oncology 500 tumor profiling DNA + RNA assay. VA uses the Personalis AC CancerPlus DNA + RNA assay to evaluate 181 clinically actionable genes or the PGDx Cancer Select 125 assay. Research analytical facilities generate next generation sequencing and multiple proteomic data. Immunoassay, cell‐free DNA, metabolomic, glycoprotein, and lipidomic data may be available in subsets.

Clinical imaging: May be acquired when accessible from medical records, imaging facilities, and research records with regulatory approval and consent at a baseline time point and as longitudinal series of collections to monitor and document disease distribution patterns and features utilizing enterprise solutions by the VA and customized solutions by DoD programs in partnership with TCIA.

Baseline details regarding imaging, including method, contrast, facility location, and dates for acquisition, curation, and submissions to and receipt of annotation.11

Disease‐oriented features will be annotated by expert radiologists using custom workstation configuration and standardized data dictionary, including assessments of mass: laterality, calcifications, thick septations, internal architecture; disease: presence, calcification, locations, shape; ascites or effusion: volume; lymphadenopathy: pathologic lymph nodes.

Computer‐generated features, including but not limited to segmentation using machine learning and artificial intelligence.

Pharmacologic therapies: Pharmacologic therapy status by regimen, treatment line, or indication with individual agent details with drug name, ICD‐O cancer site for treatment, doses, route/delivery method, cycles, date first dose/start date, date last dose/end date, dose schedule, active medication, dose reduction, treatment selection (approved assay or an integral, integrated, or exploratory biomarker), best response, and serious adverse events.

FDA indication with companion diagnostic assays: Non‐small cell lung cancer: Treat an EGFR exon 19 deletions or EGFR exon 21 L858R alterations with afatinib, gefitinib, or erlotinib; an EGFR exon 20 T790M alteration with osimertinib; ALK rearrangement with alectinib, crizotinib, or ceritinib; BRAF V600E with dabrafenib and trametinib. Melanoma: Treat BRAF V600E with dabrafenib or vemurafenib; BRAF V600E or V600K with trametinib or cobimetinib with vemurafenib. Breast cancer: Treat ERBB2/HER2 amplification with trastuzumab, ado‐trastuzumab emtansine, or pertuzumab. Colorectal cancer: Treat wild‐type KRAS (absence of mutations in codons 12 and 13) with cetuximab; wild‐type KRAS (absence of mutations in exons 2, 3, and 4) or wild‐type NRAS (absence of mutations in exons 2, 3, and 4) with panitumumab. Ovarian cancer: Treat BRCA1/2 alterations with rucaparib. Treatment of adult and pediatric patients with cancer with an NTRK fusion, including solid tumors and hematologic malignancies with larotrectinib.

Radiotherapies: Radiotherapy status by location, indication, radiation treatment line/regimen, laterality, field treated, radiation site code (ICD‐O), start date, end date, number of fractions, dose/fraction cGy, total dose cGy, best response, and best response assessment method, and comments.

Outcome assessments: If living: Disease status (alive with disease, no evidence of disease), date of last visit or date last activity if different than visit and capture individual dates of recurrence or progression with assessment method(s) and additional details when available. If deceased: Date of death and cause of death (cancer‐related, noncancer related, and unknown), if other cause then specify. Clinical trial participation will also be documented.

Epidemiologic data: May be provided directly by patients or with research staff during interviews with patients using a standardized data dictionary. Veterans may also contribute data through the Million's Veterans Program.

Patient demographics, including race, ethnicity, sex, marital status, education, employment, and military service. Medical history regarding health conditions, prior cancer diagnoses and treatments, height, and weight. Physical activity for 12 months prior to the current diagnosis. Alcohol history in entire life and currently. Tobacco products use in entire life and currently. Work environment, including occupations, exposures, and deployments. Family cancer history for blood relatives, including half blood relatives. Reproductive history for women.

Patient‐reported outcomes: Using validated instruments from trusted sources.

Patient Reported Outcomes Measurements for Personalizing Treatment (PROMPT Assessments): Quality of life using the 28‐item FACT‐G for physical, social/family, emotional, and functional well‐being. Global health using the 10‐item PROMIS Global Health version 1.2 instrument. Pain and fatigue using the 3‐item PROMIS Pain 3a and the 4‐item PROMIS Fatigue 4a instruments. Stress, anxiety, and depression combination using the 10‐item NIH ToolBox Perceived Stress, 4‐item PROMIS Anxiety 4a, and 4‐item PROMIS Depression 4a instruments. Symptoms using the 4‐item FACT‐NTX‐4, the 4‐item PROMIS Cognitive Function 4a, and the 4‐item PROMIS Sleep Disturbance 4a instruments. Support for daily living using the 11‐item PROMIS Instrumental Support version 2.0 instrument.

Focus assessments using validated instruments from trusted sources and working to deploy novel surveys to address gaps and support prevention, survivorship, palliative and end‐of‐life care to strengthen cancer capabilities across the continuum from prevention, early detection, treatment selection, mitigation of effects, rehabilitation, and survivorship, including palliative and end‐of‐life care. This may include assessments of barriers to care, patient preferences regarding treatment and care, resilience, cancer pain management, young adult survivorship, and serious adverse event reporting.

AJCC, American Joint Commission on Cancer; ALK, anaplastic lymphoma kinase; APOLLO, Applied Proteogenomics OrganizationaL Learning and Outcomes; BRAF, B‐type Raf; BRCA, breast cancer; CAP, College of American Pathologists; cGy, centigray; CLIA, Clinical Laboratory Improvement Amendment; DoD, Department of Defense; EGFR, epidermal growth factor receptor; ERBB, erythroblastic leukemia viral oncogene; FACT‐G, functional assessment of cancer therapy general; FDA, US Food and Drug Administration; HER2, human epidermal growth factor receptor 2; ICD‐10, International Classification of Disease‐10th edition; ICD‐O, International Classification of Disease for Oncology; KRAS, Kirsten RAt Sarcoma virus; NTRK, Neurotrophic tropomyosin receptor kinase; PGDx, Personal Genome Diagnostics; PROMIS, Patient‐Reported Outcomes Measurement Information System; RWD, real‐world data; TCIA, The Cancer Imaging Archive; TNM, Tumor, Node, Metastasis staging system; VA, Veteran's Affairs.