Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06140719
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2023-11-07
Brief Title:
xPedite A Study to Expedite DIPG and DMG Research
Sponsor:
xCures
Organization:
xCures
Study Overview
Official Title:
A Retrospective and Prospective Observational Sub-Study for Diffuse Midline Glioma and Diffuse Intrinsic Pontine Glioma
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will gather data from new and existing patients with patient medical records and patientfamilycaregiver 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
Detailed Description:
xPEDITE is a completely virtual decentralized nationwidereal-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 DNARNA sequencing and molecular profiling vendors and via electronic health information exchanges Medical records are received or converted to electronicdigitized 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 genomicsbiomarker 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 QCQA 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None