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ID03908502

An Observational Study in Clinical Manifestations, Therapeutic Effects, Progress, and Prognosis of Radiotherapy-related Nervous System Complications

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

On this page

AI-Summary

What this Trial Is About

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

Brief Title

A Study in Radiotherapy-related Nervous System Complications

Who Can Participate

Age: 0Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Receipt of radiotherapy
Not Eligible

You will not qualify if you...

  • Inability to sign a written informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Trial Site Locations

Total: 1 location

1

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China, 510120

Actively Recruiting

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Research Team

Y

Yamei Tang, M.D., PhD.

Y

Yi Li, M.D., PhD.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Frequently Asked Questions

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Published Research Related To This Trial

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/34650930