Gastrointestinal CancerNCT03958747
Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy
A study testing Ultrasound - Serial and Tibial Nerve, Skin Biopsy and Abbreviated Neurologic Exam in people with Gastrointestinal Cancer and Colorectal Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer, Colorectal Cancer
- What is being tested?
- Ultrasound - Serial and Tibial Nerve, Skin Biopsy and Abbreviated Neurologic Exam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2019to 26 Nov 2025
- Phase
- Interventional
- 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
Who may be able to join
- Any gastrointestinal cancer including colon, rectal, colorectal, pancreas, esophageal, or other (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.
Who cannot join
- Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of oxaliplatin chemotherapy.
- Unable to provide history.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pilot Study Using Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy
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.
Read the detailed description
Primary Objectives
- 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
- 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
- Conditions
- Gastrointestinal Cancer, Colorectal Cancer
- Being tested
- Ultrasound - Serial and Tibial Nerve, Skin Biopsy, Abbreviated Neurologic Exam, Blood draw, Nerve Conduction Study
- Medical subject headings
- Gastrointestinal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound - Serial and Tibial NerveDiagnostic test
Participants will undergo a serial and tibial nerve ultrasound
Skin BiopsyProcedure or surgery
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
Abbreviated Neurologic ExamOther
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.
Blood drawOther
12 ml blood sample will be taken
Nerve Conduction StudyDiagnostic test
Sural and tibial nerve assessments
QLQ-CIPN20 Questionnaire AdministrationOther
Self-reported neuropathy scoring questionnaire completed same day as blood draw.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Undergo peripheral nerve ultrasound Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 30 days
Secondary outcomes (9)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start17 Dec 2019
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Roy Strowd, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958747
- Sponsor's protocol ID
- IRB00059662
- Other IDs
- P30CA012197, WFBCCC 97219
- Status last verified
- Jul 2026
- First submitted
- 17 May 2019
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT03958747
- Acronym / sponsor ID
- IRB00059662
- Conditions
- Gastrointestinal Cancer, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 22 May 2019 (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 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.
Detailed description
Primary Objectives
- 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
- 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | 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 AdministrationUndergo peripheral nerve ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any gastrointestinal cancer including colon, rectal, colorectal, pancreas, esophageal, or other (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.
Key exclusion criteria (2 listed)
- Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of oxaliplatin chemotherapy.
- Unable to provide history.
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 |
|---|---|---|
| Ultrasound - Serial and Tibial NerveParticipants will undergo a serial and tibial nerve ultrasound | Diagnostic test | Ultrasound |
| Skin BiopsyTwo 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 | Procedure or surgery | Ultrasound |
| Abbreviated Neurologic ExamExam 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. | Other | Ultrasound |
| Blood draw12 ml blood sample will be taken | Other | Ultrasound |
| Nerve Conduction StudySural and tibial nerve assessments | Diagnostic test | Ultrasound |
| QLQ-CIPN20 Questionnaire AdministrationSelf-reported neuropathy scoring questionnaire completed same day as blood draw. | Other | Ultrasound |
Primary outcome
Tibial Nerve Cross-Sectional Area Comparison
Time frame: 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).
9 secondary outcomes
Sural Nerve Cross-Sectional Area Comparison
Time frame: Up to 30 days
Amplitude of Nerve Response of Tibial Nerve
Time frame: Up to 30 days
Amplitude of Nerve Response of Sural Nerve
Time frame: Up to 30 days
Distal Latency of Nerve Response of Tibial Nerve
Time frame: Up to 30 days
Distal Latency of Nerve Response of Sural Nerve
Time frame: Up to 30 days
Conduction Velocity of Nerve Response of Tibial Nerve
Time frame: Up to 30 days
Conduction Velocity of Nerve Response of Sural Nerve
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
Time frame: Up to 30 days
Reduction of Intraepidermal Nerve Fiber Density
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Gastrointestinal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
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.
Roy Strowd, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound - Serial and Tibial Nerve, Skin Biopsy and Abbreviated Neurologic Exam in people with Gastrointestinal Cancer and Colorectal Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tibial Nerve Cross-Sectional Area Comparison (time frame: Up to 30 days). 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 21 Jul 2026.