Clinical trial · Observational
Neuroinflammation in Chronic Systemic Symptoms (CSS)
Neuroinflammation in Chronic Systemic Symptoms (CSS): Proof-of-Concept Study Using PET and EEG/ERP Biomarkers
NCT04636723CI-TRIAL-00063426completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cancer Head Neck | — | UNRESOLVED | — |
| Chronic Disease | — | UNRESOLVED | — |
| Chronic Inflammation | — | UNRESOLVED | — |
| Chronic Pain | — | UNRESOLVED | — |
| Neuroinflammatory Response | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- HNC Patients w/ CSS
- description
- HNC survivor patients presenting high chronic systemic symptoms
- label
- Healthy Controls
- description
- Non-clinical controls
- label
- HNC Patients wo/ CSS
- description
- Patient Control - HNC survivor patients presenting no/low chronic systemic symptoms
Primary outcomes (1)
- measure
- Positron Emission Tomography (PET)
- timeFrame
- 12 months
- description
- Centralized Microglial Activation measured via mitochondrial translocator protein 18kDa (TSPO).
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
* Inclusion Criteria for HNC patients: * 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 * Exclusion Criteria for HNC patients: * 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. * Inclusion Criteria for healthy controls: * Age ≥ 21 * Able to speak English to understand instructions and be able to provide informed consent * Exclusion Criteria for healthy controls: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.