NCT03958747

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

December 17, 2019

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2025

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

5.9 years

First QC Date

May 17, 2019

Last Update Submit

March 16, 2026

Conditions

Gastrointestinal CancerColorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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).

    Up to 30 days

Secondary Outcomes (9)

  • Sural Nerve Cross-Sectional Area Comparison

    Up to 30 days

  • Amplitude of Nerve Response of Tibial Nerve

    Up to 30 days

  • Amplitude of Nerve Response of Sural Nerve

    Up to 30 days

  • Distal Latency of Nerve Response of Tibial Nerve

    Up to 30 days

  • Distal Latency of Nerve Response of Sural Nerve

    Up to 30 days

  • +4 more secondary outcomes

Study Arms (1)

Ultrasound

EXPERIMENTAL

Undergo peripheral nerve ultrasound

Diagnostic Test: Ultrasound - Serial and Tibial NerveProcedure: Skin BiopsyOther: Abbreviated Neurologic ExamOther: Blood drawDiagnostic Test: Nerve Conduction StudyOther: QLQ-CIPN20 Questionnaire Administration

Interventions

Skin BiopsyPROCEDURE

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

Ultrasound
Ultrasound - Serial and Tibial NerveDIAGNOSTIC_TEST

Participants will undergo a serial and tibial nerve ultrasound

Ultrasound
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.

Ultrasound
Blood drawOTHER

12 ml blood sample will be taken

Ultrasound
Nerve Conduction StudyDIAGNOSTIC_TEST

Sural and tibial nerve assessments

Ultrasound
QLQ-CIPN20 Questionnaire AdministrationOTHER

Self-reported neuropathy scoring questionnaire completed same day as blood draw.

Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of oxaliplatin chemotherapy.
  • Unable to provide history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Gastrointestinal NeoplasmsColorectal Neoplasms

Interventions

Blood Specimen CollectionNerve Conduction Studies

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesDiagnostic Techniques, NeurologicalElectrodiagnosis

Study Officials

  • Roy Strowd, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2019

First Posted

May 22, 2019

Study Start

December 17, 2019

Primary Completion

November 26, 2025

Study Completion

November 26, 2025

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)