Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539169
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
FLOWER Following Longitudinal Outcomes With Epidemiology for Rare Diseases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
FLOWER Following Longitudinal Outcomes With Epidemiology for Rare Diseases
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
FLOWER is a completely virtual nationwide real-world observational study to collect annotate standardize and report clinical data for rare diseases Patients participate in the study by electronic consent eConsent and sign a medical records release to permit data collection Medical records are accessed from institutions directly via eFax or paper fax online from patient electronic medical record EMR portals direct from DNARNA sequencing and molecular profiling vendors and via electronic health information exchanges Patients and their treating physicians may also optionally provide medical records Medical records are received in or converted to electronicdigitized formats CCDA FHIR PDF 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
Detailed Description:
This study does not require data entry by treating site staff or physicians Centralized data structuring is completed by xCures study staff Data elements are aggregated normalized and coded to OMOP-based ontologies SNOMED LOINC ICD-10 CTCAE RxNorm and MedDRA in one process permitting standardization of verbatim terms from medical records The data collection platform supports 21 CFR Part 11-compliant data annotation with formal QCQA process medical review and source data verification
Beyond EMR data raw DICOM images MRI CT files can be collected from all sites of care and anonymized for integration with the clinical data Molecular profiling and somatic or germline genomics results and biochemical lab data when available are collected from commercial and academic sources and centralized Additionally patient- and caregiver-reported outcome surveys PROs can be collected to supplement information not found in clinical records
Together these clinical imaging biomarker and assessment data will provide a comprehensive and longitudinal documentation of rare diseases in near real-time in a single observational basket study
Traditional rare disease research registries rely on patients reporting many aspects of their condition via surveys or rely on key opinion leaders at specific institutions managing a team to enroll patients and annotate necessary data These put unnecessary burdens on patients and strain limited research resources at medical centers Gathering the necessary data and in sufficient quantities is often a limitation to successfully defining the natural history of a rare disease
Beyond EMR data raw DICOM images MRI CT files can be collected from all sites of care and anonymized for integration with the clinical data Molecular profiling and somatic or germline genomics results and biochemical lab data when available are collected from commercial and academic sources and centralized Additionally patient- and caregiver-reported outcome surveys PROs can be collected to supplement information not found in clinical records
Together these clinical imaging biomarker and assessment data will provide a comprehensive and longitudinal documentation of rare diseases in near real-time in a single observational basket study
Traditional rare disease research registries rely on patients reporting many aspects of their condition via surveys or rely on key opinion leaders at specific institutions managing a team to enroll patients and annotate necessary data These put unnecessary burdens on patients and strain limited research resources at medical centers Gathering the necessary data and in sufficient quantities is often a limitation to successfully defining the natural history of a rare disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None