Spinal Cord NeoplasmNCT04533919
Validation of Pre-clinical Nano-Based Analgesics in Cells From Human Dorsal Root Ganglia
An observational study of Spinal Cord Neoplasm, run by M.D. Anderson Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Neoplasm
- What is being tested?
- Biospecimen Collection
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 Jun 2020to 30 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing surgery to resect spinal tumors
Who may be able to join
- ---All patients undergoing surgery to resect spinal tumors
Who cannot join
- ---None
About this study
Official title: Validation of Pre-Clinical Nano-Based Analgesics in Cells From Dorsal Root Ganglia
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Spinal Cord Neoplasm
- Being tested
- Biospecimen Collection
- Medical subject headings
- Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of dorsal root ganglia
| Study group | Role | What they receive |
|---|---|---|
| Basic science (dorsal root ganglia collection) | Patients' leftover dorsal root ganglia samples are collected during standard of care surgery. Receives: Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start16 Jun 2020
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Why it stopped: 0 participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Andrew J Shepherd, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533919
- Sponsor's protocol ID
- 2020-0526
- Other IDs
- NCI-2020-05249, 2020-0526
- Status last verified
- Jan 2026
- First submitted
- 5 Aug 2020
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Pre-Clinical Nano-Based Analgesics in Cells From Dorsal Root Ganglia
- ClinicalTrials.gov ID
- NCT04533919
- Acronym / sponsor ID
- 2020-0526
- Conditions
- Spinal Cord Neoplasm
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: 0 participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic science (dorsal root ganglia collection) | – | Procedure: Biospecimen CollectionPatients' leftover dorsal root ganglia samples are collected during standard of care surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing surgery to resect spinal tumors
Key inclusion criteria (1 listed)
- ---All patients undergoing surgery to resect spinal tumors
Key exclusion criteria (1 listed)
- ---None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of dorsal root ganglia | Procedure or surgery | Basic science (dorsal root ganglia collection) |
Primary outcome
Viability assays
Time frame: 3 years
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.
Functional assays
Time frame: 3 years
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- http://www.mdanderson.orgLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J Shepherd principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Neoplasm, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viability assays (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.