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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00680 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 97217 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies how well ultrasound works in detecting taxane-induced neuropathy in patients with breast cancer. Ultrasound may work better in diagnosing and detecting neuropathy in breast cancer patients treated with the chemotherapy drug called a taxane.
PRIMARY OBJECTIVES:
I. To compare tibial motor nerve ultrasound cross-sectional area (CSA) between taxane-induced peripheral neuropathy (TIPN) patients and historical data among healthy adults.
SECONDARY OBJECTIVES:
I. To compare sural sensory nerve ultrasound CSA between TIPN patients and historical data among healthy adults.
II. To determine if the above changes in nerve CSA correlate with NCS changes in the same TIPN patients.
III. To determine if the above changes in nerve CSA correlate with changes on a self-reported neuropathy scale (Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 [QLQ-CIPN20]) in the same TIPN patients.
IV. To determine if the above changes in nerve CSA correlate with intraepidermal nerve fiber (IENF) density changes on skin biopsy in the same TIPN patients.
TERTIARY OBJECTIVES:
I. To assess activated mast cells in skin biopsies in TIPN patients in relation to severity of symptoms and above findings.
II. To assess serum inflammatory markers in TIPN patients in relation to severity of symptoms and above findings.
OUTLINE:
Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy.
After completion of study, patients are followed up for 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (ultrasound) | Experimental | Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy | Procedure | Undergo skin biopsy |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Tibial Nerve Cross-sectional Area | Will be determined by ultrasound in the tibial nerve. Will be compared to the historical data from healthy patients using two-sample t-test (two-sample t-test selected as primary data from the historical control patients is available and will be used for analysis). Will also compare the nerve cross-sectional area in our study sample to that in the historical diabetic neuropathy patients and historical oxaliplatin neuropathy patients using one-sample t-test. The general linear model will be used to evaluate any factors (e.g., age) that may be associated with the nerve cross-sectional area. Due | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Amplitude of Nerve Response - Ankle | Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (amplitude of nerve response - ankle). | Up to 30 days |
| Conduction Velocity of Nerve Response - Tibial |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Levels of Inflammatory Molecules | Spearman's rank correlation coefficient will be used to assess the associations between activated mast cells in skin biopsies, serum inflammatory markers, severity of symptoms, and primary outcome and secondary outcomes in taxane-induced peripheral neuropathy patients. | Up to 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roy Strowd | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
Historical control information is a reference group only and were not active participants in this trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Case | Study sample |
| FG001 | Historical Control | Historical Control group - not part of study enrollment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2018 |
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| Questionnaire Administration | Other | Ancillary studies |
|
| Ultrasound Tomography | Diagnostic Test | Undergo peripheral nerve ultrasound |
|
Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (conduction velocity of nerve response - tibial). |
| Up to 30 days |
| Distal Latency of Nerve Response - Ankle | Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (distal latency of nerve response - ankle). | Up to 30 days |
| Nerve Fiber Density in the Skin | Spearman's rank correlation coefficient will be used to examine the association between nerve cross-sectional area and distal intraepidermal nerve fiber density. | Up to 30 days |
| Self-reported Neuropathy Score | Will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20. Spearman's rank correlation coefficient will be used to examine the associations between the cross-sectional area and the self-reported neuropathy scale. | Up to 30 days |
| Sural Nerve Cross-sectional Area | Will be determined by ultrasound of the sural nerve. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies. The general linear model will be also used to evaluate the association after adjusting for one or two risk factors (e.g., age). Nerve cross-sectional area will be treated as the dependent variable. | Up to 30 days |
| The Number of Activated Mast Cells |
Spearman's rank correlation coefficient will be used to assess the associations between activated mast cells in skin biopsies, serum inflammatory markers, severity of symptoms, and primary outcome and secondary outcomes in taxane-induced peripheral neuropathy patients. |
| Up to 30 days |
| COMPLETED |
|
| NOT COMPLETED |
|
| ID | Title | Description |
|---|---|---|
| BG000 | Case | Study sample |
| BG001 | Control (From Another Study) | These patients were not enrolled as part of this study. This data comes from another study. Each of these n=60 patients had tests done on both left and right arms, which creates the n=120 samples found in the results. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| nerve samples |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years | Participants |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tibial Nerve Cross-sectional Area | Will be determined by ultrasound in the tibial nerve. Will be compared to the historical data from healthy patients using two-sample t-test (two-sample t-test selected as primary data from the historical control patients is available and will be used for analysis). Will also compare the nerve cross-sectional area in our study sample to that in the historical diabetic neuropathy patients and historical oxaliplatin neuropathy patients using one-sample t-test. The general linear model will be used to evaluate any factors (e.g., age) that may be associated with the nerve cross-sectional area. Due | Posted | Mean | Standard Deviation | mm^2 | Up to 30 days | arm | arm |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Amplitude of Nerve Response - Ankle | Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (amplitude of nerve response - ankle). | Posted | Number | Spearman correlation coefficient | Up to 30 days | arm | arm |
|
| |||||||||||||||||||||||||||||||
| Secondary | Conduction Velocity of Nerve Response - Tibial | Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (conduction velocity of nerve response - tibial). | Posted | Number | Spearman correlation coefficient | Up to 30 days | arm | arm |
|
| |||||||||||||||||||||||||||||||
| Secondary | Distal Latency of Nerve Response - Ankle | Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (distal latency of nerve response - ankle). | Posted | Number | Spearman correlation coefficient | Up to 30 days | arm | arm |
|
| |||||||||||||||||||||||||||||||
| Secondary | Nerve Fiber Density in the Skin | Spearman's rank correlation coefficient will be used to examine the association between nerve cross-sectional area and distal intraepidermal nerve fiber density. | Posted | Number | Spearman correlation coefficient | Up to 30 days | arm | arm |
|
| |||||||||||||||||||||||||||||||
| Secondary | Self-reported Neuropathy Score | Will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20. Spearman's rank correlation coefficient will be used to examine the associations between the cross-sectional area and the self-reported neuropathy scale. | Posted | Number | Spearman correlation coefficient | Up to 30 days |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Sural Nerve Cross-sectional Area | Will be determined by ultrasound of the sural nerve. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies. The general linear model will be also used to evaluate the association after adjusting for one or two risk factors (e.g., age). Nerve cross-sectional area will be treated as the dependent variable. | Posted | Number | Spearman correlation coefficient | Up to 30 days | arm | arm |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Serum Levels of Inflammatory Molecules | Spearman's rank correlation coefficient will be used to assess the associations between activated mast cells in skin biopsies, serum inflammatory markers, severity of symptoms, and primary outcome and secondary outcomes in taxane-induced peripheral neuropathy patients. | Not Posted | Up to 30 days | Participants | ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | The Number of Activated Mast Cells | Spearman's rank correlation coefficient will be used to assess the associations between activated mast cells in skin biopsies, serum inflammatory markers, severity of symptoms, and primary outcome and secondary outcomes in taxane-induced peripheral neuropathy patients. | Not Posted | Up to 30 days | Participants |
1 month
Adverse Events were collected during the first treatment cycle. Historical control participants were not a part of this trial and were used as a reference group only. No adverse events were collected from this group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Case | Study sample | 0 | 20 | 0 | 20 | 3 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections and infestations - Other | Infections and infestations | Systematic Assessment |
| ||
| Pain of skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roy Strowd | Wake Forest Baptist Comprehensive Cancer Center | 336-713-5440 | rstrowd@wakehealth.edu |
| Apr 17, 2023 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 22, 2019 | May 8, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D000071960 | Breast Carcinoma In Situ |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| arm |
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