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CCM Blood Biomarker Validation Study

NCT05148663 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2023-09-01

No results posted yet for this study

Summary

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

  • Hemorrhagic Stroke, Intracerebral
  • Cerebral Cavernous Malformation

Interventions

DIAGNOSTIC_TEST

CCM Hemorrhagic Panel

Biomarker

Sponsors & Collaborators

  • Texas Tech University Health Sciences Center, El Paso

    lead OTHER

Principal Investigators

  • Jun Zhang · TTUHSC

Eligibility

Min Age
10 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-08-29
Completion
2023-08-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05148663 on ClinicalTrials.gov