Assessment of a Large US EHR Database as Meeting FDA Fit-for-Purpose Requirements to Provide Exte… (NCT07674095) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Assessment of a Large US EHR Database as Meeting FDA Fit-for-Purpose Requirements to Provide External Controls for Study BPM31510 in Participants With Glioblastoma
United States150 participantsStarted 2021-03-01
Plain-language summary
Glioblastoma is a rare, aggressive brain tumor that leads to death within 2 years of diagnosis in more than half of patients. There are currently 123 studies ongoing that are testing treatments for glioblastoma. BPGbio has developed BPM31510 and is executing an ongoing single-arm Phase 2 study (NCT04752813) targeting 50 participants.
Because glioblastoma is a rare and often fatal disease with multiple drugs in development, a randomized placebo-controlled trial is unlikely to be feasible. Therefore, BPGbio is exploring the possible use of untreated patients from the Truveta database to create a control group. The purpose of this study is to explore whether the Truveta database in this indication meets FDA criteria as fit-for-purpose for regulatory use.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Between 01-01-2021 and 06-30-2025, an ICD-10-CM code C71.X (malignant brain neoplasm) and/or SNOMED CT 276826005 (malignant glioma of brain)
. Between 01-01-2021 and 06-30-2025, current procedural terminology (CPT) codes indicating surgery with either a biopsy or excision of a brain tumor
. Patients must be adults at least 18 years of age at time of surgery
. CPT codes indicating submission of surgical sample for pathology for IDH testing
. SNOMED CT codes for "glioblastoma" after IDH testing
. Note that while a diagnosis can be made based on IDH from a biopsy or resection sample, resection is required for study inclusion.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Truveta participants with glioblastoma
Timeframe: 01 Jan 2021 to 30 Jun 2025
2
Completeness and quality of baseline and follow-up data in Truveta
Timeframe: 01 Jan 2021 to 30 Jun 2025
3
Quality of baseline data assessment across subgroups
Timeframe: At the index visit date with a lookback period of 12 months. All participants must have at least 12 months of EHR data before the index date.
. At least one visit meeting all eligibility criteria between 15- and 50-days post-resection.
Exclusion criteria
. History of malignant neoplasm of the brain \>12 months before index
. Patients with prior chemotherapy, radiotherapy, immunotherapy or targeted treatment agents (including anti-angiogenic drugs) less than 12 months before and/or 14 days after resection.
. Brain MRI scan post-resection available for evaluation
. Karnofsky performance score of at least 60
. Laboratory values within the following specified ranges:
. Absolute neutrophil count of at least 1.5 k/microliter (μL)
. Platelet count of at least 100 k/μL
. Hemoglobin level of at least 9 gram/deciliter (dL)