CLINICAL TRIAL

Skin Biopsy for Peripheral Nervous System Diseases

Recruiting · 18+ · All Sexes · Winston-Salem, NC

This study is evaluating whether ultrasound may be a better way to detect neuropathy in patients with gastrointestinal cancer.

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About the trial for Peripheral Nervous System Diseases

Eligible Conditions
Colorectal Carcinoma (CRC) · Gastrointestinal Neoplasms · Peripheral Nervous System Diseases · Gastrointestinal Cancers

Treatment Groups

This trial involves 2 different treatments. Skin Biopsy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Skin Biopsy
PROCEDURE
Ultrasound - Serial and Tibial Nerve
DIAGNOSTICTEST
Blood draw
OTHER
QLQ-CIPN20 Questionnaire Administration
OTHER
Abbreviated Neurologic Exam
OTHER
Nerve Conduction Study
DIAGNOSTICTEST
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Skin Biopsy
2015
Completed Phase 4
~170
Nerve Conduction Study
2009
N/A
~120

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Gastrointestinal cancer
Colorectal cancer (any stage)
Previously or currently receiving oxaliplatin -based chemotherapy.
Clinical symptoms of peripheral neuropathy noted in medical record and suspected to be secondary to oxaliplatin -based therapy.
Ability and willingness to understand and sign an informed consent.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 30 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 30 days.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Skin Biopsy will improve 1 primary outcome and 9 secondary outcomes in patients with Peripheral Nervous System Diseases. Measurement will happen over the course of Up to 30 days.

Tibial Nerve Cross-Sectional Area Comparison
UP TO 30 DAYS
Tibial nerve cross-sectional area determined by ultrasound in oxaliplatin-induced peripheral neuropathy patients will be transformed to compare to historical data previously collected from healthy adults and oxaliplatin-induced peripheral neuropathy patients using analysis of variance (ANOVA).
Conduction Velocity of Nerve Response of Sural Nerve
UP TO 30 DAYS
Conduction velocity will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
Reduction of Intraepidermal Nerve Fiber Density
UP TO 30 DAYS
Biopsies will be taken from the distal leg or proximal thigh to evaluate peripheral neuropathy. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and intraepidermal nerve fiber density.
Conduction Velocity of Nerve Response of Tibial Nerve
UP TO 30 DAYS
Conduction velocity will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
Distal Latency of Nerve Response of Tibial Nerve
UP TO 30 DAYS
Distal latency will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
Distal Latency of Nerve Response of Sural Nerve
UP TO 30 DAYS
Distal latency will be obtained from a nerve conduction study. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for peripheral nervous system diseases?

This article outlines the pharmacological treatment of PNS diseases such as PNI, CIDP and CRPS. The medications used are as diverse as the patient group. Nerve block injections and botulinum toxin injections have been used in managing sensory neuropathic pain. Additionally, a number of adjuvants such as steroids (in most cases glucocorticoids), bisphosphonates, D-Penicillamine and azathioprine have been used successfully to manage pain. The role of anticonvulsants in management of chronic pain has been studied extensively but not as thoroughly as that observed in bipolar disorder. There is high rate of spontaneous or spontaneous in the case of PNS diseases.

Anonymous Patient Answer

How many people get peripheral nervous system diseases a year in the United States?

The most common PNS disease in children <17 years of age is headache. This data must be considered when assessing the burden of health care use in this group. The most common PNS disease in children ≥17 years old is idiopathic sudden sensorineural hearing loss.

Anonymous Patient Answer

What is peripheral nervous system diseases?

PNS diseases are conditions in which a specific dysfunction in the control and organization of the nervous system exists and determines, rather than is itself determined, by a set of common causes. PNS diseases usually affect one or more of the basic nerve-motor and sensory-receptive nerve-motor systems of the autonomic, somatic, or autonomic nervous, and sensory-receptive systems. PNS diseases include all medical and surgical disorders resulting in dysfunction and diseases that affect the autonomic, somatic, or sensory-receptive nervous systems.

Anonymous Patient Answer

What are the signs of peripheral nervous system diseases?

In cases of peripheral nervous system disease, it is necessary for the family and general practitioner to recognize these signs and arrange the appropriate examinations for the patient. Peripheral neuropathies may occur in all ages, from infancy to old age. However, most are first diagnosed in late adolescence, early adulthood, or in later years after the initial onset.

Anonymous Patient Answer

What causes peripheral nervous system diseases?

The causes of peripheral nervous system diseases are not well understood because many diseases are not obvious at the time of diagnosis. The main factors related to the onset or the worsening of a peripheral nervous system disease are a history of chronic exposure to a suspected neurotoxic agent, genetic predisposition, or metabolic disorders which have a known relationship with peripheral nervous system diseases. The onset or worsening of peripheral nervous system disease is often caused by a combination of these factors or other factors not explicitly referred to. Therefore, prevention of peripheral nervous system diseases may include strategies for decreasing the exposure to suspected neurotoxic agents, modifying the genetic predisposition for peripheral nervous system diseases, and managing metabolic disorders which relate to peripheral nervous system diseases.

Anonymous Patient Answer

Can peripheral nervous system diseases be cured?

Most disorders of neural function can be controlled to some degree and the outcomes are generally good. Therefore, these disorders should not be classified as hopeless diseases.

Anonymous Patient Answer

What is the survival rate for peripheral nervous system diseases?

There appears to be low survival rates for peripheral nervous system diseases. Future research should focus on improving survival rates for peripheral nervous system diseases so that they will not be a burden to society.

Anonymous Patient Answer

Is skin biopsy typically used in combination with any other treatments?

Skin biopsy is commonly used in combination with treatment for patients being investigated for a suspected tumour, but without any treatment being suggested in almost half of the cases. Since the diagnostic yield of biopsy is low, skin biopsy should be reserved for patients with a specific diagnostic or exclusion question or to help guide a definitive management.

Anonymous Patient Answer

How does skin biopsy work?

Skin biopsy is the gold standard for the diagnosis and grading of systemic sclerosis. It is important to emphasize that it is the definitive test for the diagnosis of all forms of dermatosclerosis and connective tissue diseases.

Anonymous Patient Answer

Is skin biopsy safe for people?

This retrospective review in an advanced referral hospital in Western Australia found that skin biopsy was frequently performed as an outpatient procedure. Although the risks are not insignificant, there were few reports of major complications and serious morbidities. The procedure is often well accepted by patients.

Anonymous Patient Answer

What is the primary cause of peripheral nervous system diseases?

This comprehensive review confirms that primary PNS diseases are associated with identifiable risk factors and is likely to be related to the interaction of multiple factors.

Anonymous Patient Answer

What is the average age someone gets peripheral nervous system diseases?

The average age of first onset of PNSWDI has not changed, and the average age of symptom onset has risen by 4+ years in recent years. In a recent study, findings suggest that the average age of onset of PNSWDI is now approximately 43 years of age.

Anonymous Patient Answer
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