Clinical trial · Observational
CCM Blood Biomarker Validation Study
CCMs Among Hispanic Population Study Group (CHIPS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Leaving the institution
Summary
Brief summary (as posted)
Cerebral cavernous malformations (CCMs), one of the most common microvascular malformations in the capillary beds of the brain, are susceptible to hemorrhagic stroke. As an autosomal dominant disorder with incomplete penetrance, the majority of CCM gene mutation carriers are largely asymptomatic but when symptoms occur, the disease has typically reached the stage of focal hemorrhage with irreversible brain damage. Currently, the invasive neurosurgery removal of CCM lesions is the only treatment option, despite the recurrence of the symptoms after surgery. Therefore, there is a grave need for prognostic/monitoring biomarkers as risk predictors for stroke prevention. The objective of the proposal is to develop a set of blood prognostic/monitoring biomarkers as precise risk indicators for stroke prevention. In this project, the plan is to validate the novel serum biomarkers identified in Ccms animal models and human CCMs patients, and utilize these biomarkers with statistical algorithms for risk prediction of hemorrhagic CCMs. This proposal has been formulated based on recent findings of five serum etiological biomarkers associated with disruption of the Blood-Brain Barrier (BBB), the first step for hemorrhagic CCMs in Ccm mice models. This work will lay the groundwork for larger human trials for final validation and revolutionary potential clinical applications.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cerebral Cavernous Malformation | — | UNRESOLVED | — |
| Hemorrhagic Stroke, Intracerebral | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CCM Hemorrhagic Panel | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- blood drawing and hemorrhagic events in CCM patients
- description
- planned for three blood drawing before surgery
- interventionNames
- Diagnostic Test: CCM Hemorrhagic Panel
- label
- blood drawing for age/gender/ethnicity matched controls
- description
- Blood draw from Control patients with no inflammation
- interventionNames
- Diagnostic Test: CCM Hemorrhagic Panel
Primary outcomes (1)
- measure
- Identification and validation of at least (>1) biomarker(s) with a significant p-value (p≤ 0.001) to correlate with the progression of hemorrhagic events in CCM patients using our optimized ELISAs.
- timeFrame
- the first two years
- description
- Confirmation of at least (\>1) biomarker(s) is essential for the feasibility assessment of this project after three years investigation and validation in the mid-sized cohorts (\~300 each cases/controls). Thus, to assess the consistency of the measurement between different CCM cohorts at the end of the 1st phase, the blinded test-retest reliability (r2) will be calculated with a relatively strong outcome range (\~0.65-0.70, p=0.005) on at least (\>1) positively/negatively correlated biomarker(s).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 78 Years
Show eligibility criteria text
Inclusion Criteria: 1. 10 to 78 years of age. 2. Medical history meets the criteria for the International Classification of Diseases diagnosis codes 10 (ICD-10) for cerebral cavernous malformations (CCMs) (Q28.3) or stroke/epilepsy. 3. Has a family member whose medical history meets the criteria for the International Classification of Diseases diagnosis codes for cerebral cavernous malformations (CCMs) (Q28.3) or stroke/epilepsy. 4. Has a relatively complete medical history that can be accurately confirmed by an interview or electronic and/or paper medical records. 5. Hispanic and non-Hispanic Americans. Exclusion Criteria: N/A
References
Publications (0)
Data not yet available