An interventional study of Ultrasound - Serial and Tibial Nerve and Skin Biopsy in Gastrointestinal Cancer and Colorectal Cancer, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Diagnostic
This pilot clinical trial studies how well ultrasound works in detecting oxaliplatin-induced neuropathy in participants with gastrointestinal cancer. Ultrasound may work better in diagnosing and detecting neuropathy in gastrointestinal cancer participants treated with the chemotherapy drug called oxaliplatin.
Primary Objectives
I. To compare tibial motor nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults.
and oxaliplatin-induced peripheral neuropathy patients
II. To compare sural sensory nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults and oxaliplatin-induced peripheral neuropathy patients
Secondary Objectives
I. To determine if the above changes in nerve cross-sectional area correlate with nerve conduction studies changes in the same oxaliplatin-induced peripheral neuropathy participants
II. To determine if the above changes in nerve cross-sectional area correlate with changes on a self-reported neuropathy scale (QLQ-CIPN20) in the same oxaliplatin-induced peripheral neuropathy participants
III. To determine if the above changes in nerve cross-sectional area correlate with intraepidermal nerve fiber density changes on skin biopsy in the same oxaliplatin-induced peripheral neuropathy participants
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
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Exclusion Criteria:
Undergo peripheral nerve ultrasound
Diagnostic Test: Ultrasound - Serial and Tibial Nerve · Procedure: Skin Biopsy · Other: Abbreviated Neurologic Exam · Other: Blood draw · Diagnostic Test: Nerve Conduction Study · Other: QLQ-CIPN20 Questionnaire Administration
Participants will undergo a serial and tibial nerve ultrasound
Two skin biopsies will be obtained as 4.0 mm punch biopsies at distal end of leg in sural nerve territory (10 cm above lateral malleolus) and from the thigh
Exam to include strength assessment of the tibialis anterior and gastrocnemius and deep tendon reflex exam of the Achilles on the limb to be examined by nerve conduction velocity and ultrasound.
12 ml blood sample will be taken
Sural and tibial nerve assessments
Self-reported neuropathy scoring questionnaire completed same day as blood draw.
Tibial Nerve Cross-Sectional Area Comparison
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).
Time frame: Up to 30 days
Sural Nerve Cross-Sectional Area Comparison
Sural 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).
Time frame: Up to 30 days
Amplitude of Nerve Response of Tibial Nerve
Amplitude 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.
Time frame: Up to 30 days
Amplitude of Nerve Response of Sural Nerve
Amplitude 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.
Time frame: Up to 30 days
Distal Latency of Nerve Response of Tibial Nerve
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.
Time frame: Up to 30 days
Distal Latency of Nerve Response of Sural Nerve
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.
Time frame: Up to 30 days
Conduction Velocity of Nerve Response of Tibial Nerve
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.
Time frame: Up to 30 days
Conduction Velocity of Nerve Response of Sural Nerve
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.
Time frame: Up to 30 days
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20) Questionnaire
The EORTC QLQ-CIPN20 is a 20-item patient-reported questionnaire evaluating chemotherapy-induced peripheral neuropathy symptoms across sensory, motor, and autonomic subscales. Items are scored from 1 (Not at all) to 4 (Very much) based on the past week, with scores linearly converted to a 0-100 scale. Higher scores indicate greater symptom severity.
Time frame: Up to 30 days
Reduction of Intraepidermal Nerve Fiber Density
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.
Time frame: Up to 30 days
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Plan to share: No
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Wake Forest University Health Sciences