Bevacizumab Combined with Corticosteroids Does Not Improve the Clinical Outcome of Nasopharyngeal Carcinoma Patients With Radiation-Induced Brain Necrosis.
Honghong Li, Xiaoming Rong, Weihan Hu...
https://pubmed.ncbi.nlm.nih.gov/34650930Actively Recruiting
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-07-25
4000
Participants Needed
1
Research Sites
N/A
Total Duration
This observational study focuses on patients who have developed nervous system complications related to radiotherapy, often used in treating head and neck tumors and cancers of the central nervous system. Researchers aim to understand the clinical signs, treatment effects, disease progression, and prognosis of these complications, which can range from mild changes to severe neurological damage such as brain necrosis and nerve injury. The study is conducted with the involvement of Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Participants receive optimized clinical treatment while being observed over time. Regular evaluations include blood, urine, stool, and cerebrospinal fluid tests alongside imaging techniques like MRI, CT, and ultrasound. Additional examinations such as hearing tests, eye exams, and neurological function scales are performed to assess the impact of radiotherapy on the nervous system. Researchers also collect biological samples to study genes, proteins, and metabolites involved in these complications, including analysis of gut microbiota interactions. During the study, participants undergo various assessments to monitor neurological function, psychiatric conditions, cognitive status, quality of life, pain, and drug side effects using multiple validated scales. Blood and stool samples are regularly collected, and cerebrospinal fluid or biopsy samples may be taken if necessary. The primary outcome measure is overall survival, tracked from the start of the study up to 20 years or until death. The study involves ongoing follow-up and monitoring to gather comprehensive data on the condition and treatment outcomes.
CONDITIONS
A Study in Radiotherapy-related Nervous System Complications
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 20 years or until death
Participants who have received radiotherapy are observed to assess clinical manifestations, therapeutic effects, progression, and prognosis of radiotherapy-related nervous system complications through various examinations and assessments.
Periodic visits for blood, urine, stool, imaging, neurological, and psychiatric assessments
Total: 1 location
1
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Y
Yamei Tang, M.D., PhD.
Y
Yi Li, M.D., PhD.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Honghong Li, Xiaoming Rong, Weihan Hu...
https://pubmed.ncbi.nlm.nih.gov/34650930