Neuroinflammation in Chronic Systemic Symptoms (CSS)
1 other identifier
observational
30
1 country
1
Brief Summary
The purpose of the present research protocol is to investigate and identify translocator protein 18kDa, MRI DTI, and EEG/ERPs, markers of Chronic Systemic Symptoms (CSS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2020
CompletedFirst Posted
Study publicly available on registry
November 19, 2020
CompletedStudy Start
First participant enrolled
February 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2021
CompletedJanuary 26, 2023
January 1, 2023
10 months
November 13, 2020
January 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Positron Emission Tomography (PET)
Centralized Microglial Activation measured via mitochondrial translocator protein 18kDa (TSPO).
12 months
Secondary Outcomes (6)
EEG/ERP concomitant to working memory neurobehavioral task
12 months
EEG/ERP concomitant to sustained attention neurobehavioral task
12 months
Diffusion Tensor Imaging (DTI)
12 months
Peripheral Cytokine and Chemokine Inflammation
12 months
Peripheral Cytokine and Chemokine Inflammation
12 months
- +1 more secondary outcomes
Other Outcomes (6)
Clinical Measure: Vanderbilt Head and Neck Symptom Survey (VHNSS) version 2.0 plus general symptom survey (GSS)
12 months
Clinical Measure: Neurotoxicity Rating Scale (NRS)
12 months
Clinical Measure: Central Sensitivity Inventory (CSI)
12 months
- +3 more other outcomes
Study Arms (3)
HNC Patients w/ CSS
HNC survivor patients presenting high chronic systemic symptoms
Healthy Controls
Non-clinical controls
HNC Patients wo/ CSS
Patient Control - HNC survivor patients presenting no/low chronic systemic symptoms
Eligibility Criteria
10x HNC patients will be recruited via Vanderbilt's Department of Otolaryngology. 10x Healthy controls will be recruited via VUMC recruitment listserv and ResearchMatch.
You may qualify if:
- Age ≥ 21
- HNC of larynx, pharynx, oral cavity paranasal sinus, salivary gland, or unknown primary
- Any histology of any epithelial origin
- Completed therapy a minimum of 3 months prior to study entry
- At least two systemic symptoms on the VHNSS-GSS subscale
- Able to speak English to understand instructions and be able to provide informed consent
You may not qualify if:
- History of neurodegenerative disease, unrelated to cancer history/treatment
- Alcohol/substance abuse/dependence within the last 6 months
- Current or previous co-morbid bipolar disorder-, psychosis-, obsessive compulsive disorder-, eating disorders-, personality disorders-,
- Neurological disorders unrelated to cancer and its treatment (e.g. ADHD, ASDs, epilepsy)
- Learning difficulties.
- Age ≥ 21
- Able to speak English to understand instructions and be able to provide informed consent
- History of HNC of larynx, pharynx, oral cavity paranasal sinus, salivary gland, or unknown primary
- Alcohol/substance abuse/dependence within the last 6 months
- Current or previous co-morbid bipolar disorder-, psychosis-, obsessive compulsive disorder-, eating disorders-, personality disorders-,
- Neurological disorders (e.g. ADHD, ASDs, epilepsy)
- Learning difficulties.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
Biospecimen
Blood Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Poppy Schoenberg, PhD
Osher Center for Integrative Medicine, VANDERBILT UNIVERSITY MEDICAL CENTER
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
November 13, 2020
First Posted
November 19, 2020
Study Start
February 22, 2021
Primary Completion
December 7, 2021
Study Completion
December 7, 2021
Last Updated
January 26, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- 24 months
The PI will adhere to the NIH Sharing of Biomedical Research Resources: Guidelines for Recipients of NIH Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources. 1. Quality-controlled raw data as well as processed data used in publications will be de-identified before sharing upon "reasonable request". As described in the proposal, workflows and structure will be exactly described in reports and documented to allow precisely reproduce results from raw data and replicate methodology. Final data (computerized datasets with raw data and derived variables) that have not yet been published will be shared in a timely manner. 2. Software programs (i.e. experimental paradigm scripts produced for this study) and documentation will be made available for research purposes to replicate findings upon "reasonable request", and any software/script sharing requirements by journals.