Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05148663 · ClinicalTrials.gov registry record
CCM Blood Biomarker Validation Study
A clinical trial, sponsored by Texas Tech University Health Sciences Center, El Paso.
- Terminated
- Registry status
- 12
- Enrollment target
NCT05148663: Clinical Trial study, sponsored by Texas Tech University Health Sciences Center, El Paso.
NCT05148663 is a clinical trial that was terminated before completion, run by Texas Tech University Health Sciences Center, El Paso. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05148663 was terminated before completion, sponsored by Texas Tech University Health Sciences Center, El Paso.
- TERMINATED
- Registry status
- 12 participants
- Enrollment target
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.
Primary Outcome
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)
Interventions
- DIAGNOSTIC_TEST CCM Hemorrhagic Panel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2023-08-29 |
Why NCT05148663 stopped before completion
NCT05148663 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which CCM Hemorrhagic Panel is the first listed.
NCT05148663 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05148663 about?
NCT05148663 is a clinical study titled "CCM Blood Biomarker Validation Study". 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...
What is the current status of trial NCT05148663?
This trial is currently terminated. The enrollment target is 12 participants. The study started on 2021-01-01. Estimated completion is 2023-08-29.
What interventions are being tested in trial NCT05148663?
The interventions under investigation include: CCM Hemorrhagic Panel (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05148663?
This trial is sponsored by Texas Tech University Health Sciences Center, El Paso, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02602769 · 12 participants
Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome
- NCT02605421 · 12 participants · Phase 2
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
- NCT02619448 · 12 participants · Early Phase 1
Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC
- NCT03311503 · 12 participants · Phase 1
Phase I/II Trial of Lentiviral Gene Transfer for SCID-X1 With Low Dose Targeted Busulfan Conditioning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI