Validation of Pre-clinical Nano-Based Analgesics in Cells From Human Dorsal Root Ganglia

NCT04533919 | Recruiting

• 2 other identifiers: 2020-0526NCI-2020-05249
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Basic science (dorsal root ganglia collection)

Patients' leftover dorsal root ganglia samples are collected during standard of care surgery.

Procedure: Biospecimen Collection

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of dorsal root ganglia

Basic science (dorsal root ganglia collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing surgery to resect spinal tumors

You may qualify if:

• All patients undergoing surgery to resect spinal tumors

You may not qualify if:

• None

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• http://www.mdanderson.org

Biospecimen

Retention: SAMPLES WITH DNA

Dorsal root ganglia

MeSH Terms

Conditions

Spinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Andrew J Shepherd

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew J. Shepherd

CONTACT

713-745-7959; ajshepherd@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: September 1, 2020
• Study Start: June 16, 2020
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (1)