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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-05249 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0526 | Other Identifier | M D Anderson Cancer Center |
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0 participants
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study investigates the pre-clinical nano-based analgesics in cells from human dorsal root ganglia (clusters of neurons). Collecting these neurons may help future research related to safe and effective pain treatment.
PRIMARY OBJECTIVE:
I. To identify translational mechanisms and therapeutics for neuropathic pain, a type of chronic pain that can arise due to injured nerves.
OUTLINE:
Patients' leftover dorsal root ganglia samples are collected during standard of care surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basic science (dorsal root ganglia collection) | Patients' leftover dorsal root ganglia samples are collected during standard of care surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of dorsal root ganglia |
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| Measure | Description | Time Frame |
|---|---|---|
| Viability assays | The Viability outcome measure will be expressed using percentage units. This will be calculated as the percentage of cells in culture that are able to exclude a cell permeable dye (Ethidium homodimer) from their nucleus. Entry of this dye into the nucleus and fluorescent binding to nuclear DNA is indicative of a dead/dying cell. Cultured cells that have undergone control or active nanoemulsion treatment in vitro will be loaded with a fluorescent calcium-sensitive dye and continuously monitored while excitation is evoked with a panel of ion channel agonists. The fold-change in intracellular calcium concentration over baseline in response to such excitation is the outcome measure. | 3 years |
| Functional assays | Neurons will be isolated from fresh tissues and used in assays in which cells are stimulated with pronociceptive chemicals (e.g. agonists for ion channels, pattern recognition receptors, G protein-coupled receptors). Cell activity will be quantified as appropriate (e.g. calcium mobilization). Experimental endpoints will be analyzed using a between-subjects designs to assess differences between patients with and without nerve compression. ANOVA will be performed in a 2 (neuropathic pain vs. control) x 4 (3 treatments vs. control) design. Bonferroni posthoc tests will be applied when significant interactions are found. Age, sex, ethnicity, cancer diagnosis, drug treatments, and history of chronic pain will be included as covariates. | 3 years |
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Inclusion Criteria:
---All patients undergoing surgery to resect spinal tumors
Exclusion Criteria:
---None
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All patients undergoing surgery to resect spinal tumors
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| Name | Affiliation | Role |
|---|---|---|
| Andrew J Shepherd | M.D. Anderson Cancer Center | Principal Investigator |
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| Label | URL |
|---|---|
| http://www.mdanderson.org | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 27, 2020 | Feb 4, 2026 | ICF_000.pdf |
| ID | Term |
|---|---|
| D013120 | Spinal Cord Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Dorsal root ganglia
| D013118 |
| Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |