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Recruitment/accrual impacted by COVID and technical issues with equipment
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This is a cross-sectional pilot study of head and neck cancer survivors who have completed multi-modal treatment to assess and characterize the presence of distinct pain syndromes.
Primary objectives:
Exploratory objectives:
- DNA, RNA, and plasma will be collected for genomic, transcriptomic, and proteomic studies. Results will be vertically integrated along with the results of clinical studies described within this protocol to identify targets for future correlative studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Response to Pain | Experimental | Brain's response to pain using magnetic resonance imaging (MRI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPC-1000 | Device | Delivers pressure to thumbnail for five seconds at a time |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic Resonance Imaging (MRI) to Correlate With One of Three Pain Phenotypes 1) no Pain, 2) Central Pain, 3) Nociceptive Pain | MRI scan of brain to measure response to stimulated pressure to thumbnail | Approximately 8 weeks |
| Magnetic Resonance Imaging (MRI) to Correlate Presence of Chronic Systemic Symptoms With Pain Phenotype | MRI scan of brain to measure response to stimulated pressure to thumbnail | Approximately 8 weeks |
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Inclusion Criteria:
Patients with histologically proven head and neck cancer
Patients without a diagnosis of head and neck cancer (up to 10 patients, see below)
Completed multi-modality therapy a minimum of 6 weeks prior to study entry.
Willing and able to provide informed consent
All participants must be at least 21 years of age
Able to speak English
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dianne Lou, MD, PhD | Vanderbilt Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
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This study enrolled participants at Vanderbilt University Medical Center from November 4, 2019 to July 21, 2022. The study stopped early due to low accrual and technical issues with equipment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Response to Pain | Brain's response to pain using magnetic resonance imaging (MRI) IPC-1000: Delivers pressure to thumbnail for five seconds at a time Magnetic resonance imaging: Scan of brain using Magnetic resonance imaging Correlative Studies: Administration of questionnaires via computer |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Response to Pain | Brain's response to pain using magnetic resonance imaging (MRI) IPC-1000: Delivers pressure to thumbnail for five seconds at a time Magnetic resonance imaging: Scan of brain using Magnetic resonance imaging Correlative Studies: Administration of questionnaires via computer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Magnetic Resonance Imaging (MRI) to Correlate With One of Three Pain Phenotypes 1) no Pain, 2) Central Pain, 3) Nociceptive Pain | MRI scan of brain to measure response to stimulated pressure to thumbnail | Data were not collected due to the technical issues. | Posted | Approximately 8 weeks |
|
|
From date of enrollment until 30 days after completing last study intervention, on average of 3 months
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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 | Response to Pain | Brain's response to pain using magnetic resonance imaging (MRI) IPC-1000: Delivers pressure to thumbnail for five seconds at a time Magnetic resonance imaging: Scan of brain using Magnetic resonance imaging Correlative Studies: Administration of questionnaires via computer |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Teresa Melton | Vanderbilt-Ingram Cancer Center | (615) 936-7423 | teresa.melton@vumc.org |
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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 | Aug 31, 2020 | Jul 28, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 30, 2021 | Mar 2, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Magnetic resonance imaging |
| Device |
Scan of brain using Magnetic resonance imaging |
|
| Correlative Studies | Other | Administration of questionnaires via computer |
|
| Participant had other medical issues |
|
| Participant failed to respond to multiple attempts to contact |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
| Primary | Magnetic Resonance Imaging (MRI) to Correlate Presence of Chronic Systemic Symptoms With Pain Phenotype | MRI scan of brain to measure response to stimulated pressure to thumbnail | Data were not collected due to the technical issues. | Posted | Approximately 8 weeks |
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| 3 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
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