- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06140719
xPedite: A Study to Expedite DIPG and DMG Research
February 15, 2024 updated by: xCures
A Retrospective and Prospective Observational Sub-Study for Diffuse Midline Glioma and Diffuse Intrinsic Pontine Glioma
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.
Study Overview
Detailed 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.
Study Type
Observational
Enrollment (Estimated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: xCures Study Team
- Phone Number: 707-641-4475
- Email: navigator@xcures.com
Study Locations
-
-
California
-
Los Altos, California, United States, 94022
- Recruiting
- xCures, Inc.
-
Contact:
- Bryan Federowicz
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Up to 400 patients of any age who have been diagnosed with diffuse midline glioma (DMG) or diffuse intrinsic pontine glioma (DIPG).
Description
Inclusion Criteria:
- Diagnosis of diffuse midline glioma according to the WHO 2021 Classification of Tumors of the Central Nervous System diagnostic criteria including diffuse intrinsic pontine glioma (DIPG). In the absence of a pathologically confirmed diagnosis, a grade IV glioma involving the thalamus, hypothalamus, brainstem, cerebellum, midbrain, or spinal cord, or with a pontine epicenter and diffuse involvement of the pons.
- Patients with any performance status, comorbidity or disease severity are eligible
- Patients or their legally-authorized representative must be willing and able to provide electronic, informed consent (and assent, if applicable)
- Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088).
- Patients must be a resident of or receiving care within the United States or US territories.
Exclusion Criteria:
- Patient or legally-authorized representative is unable to provide informed consent.
- Patient or caregiver is unable to complete the PRO and ClinRO by an electronic platform.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate progression-free survival rate at 6 Months
Time Frame: 6 Months
|
To evaluate PFS rate at 6 months of standard of care treatments by mRANO in subjects with DIPG or DMG
|
6 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate Duration of Clinical Benefit (DOCB)
Time Frame: Up to 12 months
|
DOCB defined as time from date of first documented objective response (CR or PR) and SD to first documented progression or death due to any cause.
|
Up to 12 months
|
To evaluate clinical benefit rate Clinical Benefit Rate (CBR) (Complete Response (CR), Partial Response (PR), and Stable Disease (SD)
Time Frame: Up to 12 months
|
CBR defined as the proportion of subjects with a BOR of CR or PR or SD.
|
Up to 12 months
|
To evaluate OS (Overall Survival)
Time Frame: Up to 12 months
|
OS, defined as time from first dose of treatment to death due to any cause.
|
Up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Shapiro, PhD, xCures
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
November 7, 2023
First Submitted That Met QC Criteria
November 14, 2023
First Posted (Actual)
November 20, 2023
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 15, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Brain Neoplasms
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Brain Stem Neoplasms
- Infratentorial Neoplasms
- Diffuse Intrinsic Pontine Glioma
Other Study ID Numbers
- XPED-2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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