Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06140719 |
| Other study ID # |
XPED-2023 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2023 |
| Est. completion date |
January 2027 |
Study information
| Verified date |
April 2024 |
| Source |
xCures |
| Contact |
xCures Study Team |
| Phone |
707-641-4475 |
| Email |
navigator[@]xcures.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study will gather data from new and existing patients with patient medical records, and
patient/family/caregiver reported information to establish a clear natural history of disease
suitable to serve as an external, contemporary or historical control arm for future
therapeutic development programs of drugs, devices, or biologic interventions in DMG or DIPG.
Description:
xPEDITE is a completely virtual, decentralized, nationwide,real-time, real-world
observational study to collect, annotate, standardize, and report the critical data elements
of DMG, inclusive of DIPG, in a regulatory-compliant framework. Patients participate by
eConsent to the pan-cancer master observational protocol XCELSIOR (NCT03793088). This
protocol is a sub-study of XCELSIOR and does not require an additional written consent.
Medical records are accessed from institutions directly via eFax or paper fax, online from
patient EMR portals, direct from DNA/RNA sequencing and molecular profiling vendors, and via
electronic health information exchanges. Medical records are received or converted to
electronic/digitized formats (CCDA, FHIR, PDF) and sorted by medical record type (clinic
visit, in-patient hospital, out-patient clinic, infusion and out-patient pharmacies, etc.)
and made machine-readable to support data annotation, full text searches, and natural
language processing (NLP) algorithms to further facilitate feature identification. Data
elements are annotated comprehensively and longitudinally from diagnosis to final outcome and
include patient level clinical features required to report endpoints in DMG and DIPG clinical
trials such as anti-cancer interventions, non-cancer medications, genomics/biomarker results,
radiological endpoints, steroid use, vitals, demographics, and locations of care, among
others. This study does not require data entry by treating site staff or physicians.
Centralized data annotation is completed by xCures remote study staff. Data elements are
annotated in a central electronic data capture (EDC) system and coded to Observational
Medical Outcomes Partnership (OMOP)-based ontologies (SNOMED, LOINC, ICD-O-3, CTCAE, RxNorm,
MedDRA, and others) in one process, permitting standardization of verbatim terms from medical
records. Data is collected in a 21 CFR Part 11-compliant EDC system with formal QC/QA
process, medical review, and source data verification. Beyond EMR data, raw DICOM images
(MRI, CT files) are collected from all sites of care and de-identified. Imaging will be
subjected to a blinded central radiological review to assess sizes, and response or
progression. For all patients, genomics results (PDFs, variant call files, and raw FASTQ
files when available) are collected from commercial and academic sources and centralized.
Additionally, patient- and caregiver-reported outcome questionnaires (PROs) are collected to
measure the impact of disease and medical care on the patient and family and others living
around them to determine the aspects of care that are most important to them. Mobility and
neurological assessments will be videoed and submitted at regular intervals to prospectively
document changes in clinical status by expert electronic clinician-reported outcomes
(ClinROs). Together, these clinical, imaging, biomarker, and assessment data will provide a
comprehensive and longitudinal documentation of DMG and DIPG disease course.
