Nervous System ComplicationNCT03908502
A Study in Radiotherapy-related Nervous System Complications
An observational study of Nervous System Complication, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Purpose: This observational study aims to evaluate the clinical manifestations, therapeutic effects, progress and prognosis in radiotherapy-related nervous system complications. OUTLINE: This is an observational clinical trial. Patients are enrolled and administrated with optimized clinical treatment. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Nervous System Complication
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 31 Dec 2037
- How long will I take part?
- 60 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Radiotherapy is a key component in the management of head and neck tumors and primary or metastatic cancer of the central nervous system. The outcomes of various radiation protocols may be complicated by radiation effects on normal brain parenchyma and other nervous system, resulting in a spectrum of phenotypes that range from clinically asymptomatic changes to radiotherapy-related nervous system complications with severe neurological defects, including delayed radiation-induced brain necrosis, myelopathy and nerve injury.
Who may be able to join
- Receipt of radiotherapy
Who cannot join
- Inability to sign a written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Yamei Tang, M.D., PhD.
About this study
Official title: An Observational Study in Clinical Manifestations, Therapeutic Effects, Progress, and Prognosis of Radiotherapy-related Nervous System Complications
Purpose: This observational study aims to evaluate the clinical manifestations, therapeutic effects, progress and prognosis in radiotherapy-related nervous system complications.
OUTLINE: This is an observational clinical trial. Patients are enrolled and administrated with optimized clinical treatment. Blood, urine, stool, cerebrospinal fluid (CSF), imaging and other examinations, and scale assessments are regularly performed to evaluate the state of the disease.
Further study details are provided by Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University/Yamei Tang.
Primary outcome measure: The primary endpoint is overall survival.
Read the detailed description
BACKGROUND
Radiotherapy is a key component in the management of head and neck tumors and primary or metastatic cancer of the central nervous system. Various radiation treatment methods employ different types of fractionation and conformational protocols designed to deliver focused radiation to target regions to maximize the lethal effect on the neoplasm and minimize the extraneous dose on normal brain tissue and other adjacent organs at risk. The outcomes of these clinical protocols may be complicated by radiation effects on normal brain parenchyma and other nervous system, resulting in a spectrum of phenotypes that range from clinically asymptomatic changes to radiotherapy-related nervous system complications with severe neurological defects, including delayed radiation-induced brain necrosis, myelopathy and nerve injury.
STUDY DESIGN:
Interventions Patients are enrolled and administrated with optimized clinical treatment.
Follow-up examinations
- Blood, urine and stool examinations, such as biochemical A, coagulation routine, thyroid function, EB virus DNA, erythrocyte sedimentation rate, morning cortisol, urine sodium and potassium, gonadal hormone, growth hormone, glycosylated hemoglobin.
- Imaging examinations, such as MR, CT, ultrasound. X ray is performed if needed.
- Other examinations, such as pure tone audiometry, fundus exam, visual exam, VEP, OCTA, visual field exam.
- Scale assessments about neurological function, radiation injury, common psychiatric disorders, cognitive function, quality of life, drug side effect, sleep and pain, such as LENT/SOMA, WHO-QOL, MoCA, MMSE, Hamilton anxiety scale, Hamilton depression scale, Pain numerical rating scale, Drug side effect scale, ADAS-cog, fatigue self-assessment scale (FSAS), Neuropsychiatric Inventry (NPI) total score, Clinical Dementia Rating Scale, Barthel index, UPDRS, Self-Rating Scale of Sleep (SRSS), NCI-CTCAE, CIBIC-plus and SSA.
- Blood sample are obtained in order to investigate significant genes, proteins and metabolites involved in the development and progress of radiotherapy-related nervous system complications. Genomics, metabolomics and proteomics are performed to detect potential genes, proteins and metabolites. Stool sample are obtained in order to investigate interactions between the gut microbiota, immune and nervous systems in radiotherapy-related nervous system complications. Cerebrospinal fluid (CSF) and biopsy samples are obtained if needed.
- Conditions
- Nervous System Complication
- Keywords
- Radiotherapy, Nervous System Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival is the duration between the first day of study enrollment to death. For participants who are alive, overall survival is censored at the last contact.
Measured: Baseline until death or up to Year 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Jun 2017
- Primary completion31 Dec 2037 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nervous System ComplicationStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 60 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Yamei Tang, M.D., PhD., Study director, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908502
- Sponsor's protocol ID
- 20170601001
- Status last verified
- Jul 2023
- First submitted
- 2 Apr 2019
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zuo X, Chen Y, Zhu Y, Pan D, Rong X, Shen Q, Li H, Xu Y, Tang Y. Radiation-induced Chronic Pain Plagues Head and Neck Cancer Survivors: A Cross-sectional Analysis From the Cohort in Radiotherapy-related Nervous System Complications. J Pain. 2024 Oct;25(10):104612. doi: 10.1016/j.jpain.2024.104612. Epub 2024 Jun 20.
PubMed 38908498Li H, Rong X, Hu W, Yang Y, Lei M, Wen W, Yue Z, Huang X, Chua MLK, Li Y, Cai J, He L, Pan D, Cheng J, Pi Y, Xue R, Xu Y, Tang Y. Bevacizumab Combined with Corticosteroids Does Not Improve the Clinical Outcome of Nasopharyngeal Carcinoma Patients With Radiation-Induced Brain Necrosis. Front Oncol. 2021 Sep 28;11:746941. doi: 10.3389/fonc.2021.746941. eCollection 2021.
PubMed 34650930
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study in Clinical Manifestations, Therapeutic Effects, Progress, and Prognosis of Radiotherapy-related Nervous System Complications
- ClinicalTrials.gov ID
- NCT03908502
- Acronym / sponsor ID
- 20170601001
- Conditions
- Nervous System Complication
- Keywords
- Radiotherapy, Nervous System Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2037 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: This observational study aims to evaluate the clinical manifestations, therapeutic effects, progress and prognosis in radiotherapy-related nervous system complications.
OUTLINE: This is an observational clinical trial. Patients are enrolled and administrated with optimized clinical treatment. Blood, urine, stool, cerebrospinal fluid (CSF), imaging and other examinations, and scale assessments are regularly performed to evaluate the state of the disease.
Further study details are provided by Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University/Yamei Tang.
Primary outcome measure: The primary endpoint is overall survival.
Detailed description
BACKGROUND
Radiotherapy is a key component in the management of head and neck tumors and primary or metastatic cancer of the central nervous system. Various radiation treatment methods employ different types of fractionation and conformational protocols designed to deliver focused radiation to target regions to maximize the lethal effect on the neoplasm and minimize the extraneous dose on normal brain tissue and other adjacent organs at risk. The outcomes of these clinical protocols may be complicated by radiation effects on normal brain parenchyma and other nervous system, resulting in a spectrum of phenotypes that range from clinically asymptomatic changes to radiotherapy-related nervous system complications with severe neurological defects, including delayed radiation-induced brain necrosis, myelopathy and nerve injury.
STUDY DESIGN:
Interventions Patients are enrolled and administrated with optimized clinical treatment.
Follow-up examinations
- Blood, urine and stool examinations, such as biochemical A, coagulation routine, thyroid function, EB virus DNA, erythrocyte sedimentation rate, morning cortisol, urine sodium and potassium, gonadal hormone, growth hormone, glycosylated hemoglobin.
- Imaging examinations, such as MR, CT, ultrasound. X ray is performed if needed.
- Other examinations, such as pure tone audiometry, fundus exam, visual exam, VEP, OCTA, visual field exam.
- Scale assessments about neurological function, radiation injury, common psychiatric disorders, cognitive function, quality of life, drug side effect, sleep and pain, such as LENT/SOMA, WHO-QOL, MoCA, MMSE, Hamilton anxiety scale, Hamilton depression scale, Pain numerical rating scale, Drug side effect scale, ADAS-cog, fatigue self-assessment scale (FSAS), Neuropsychiatric Inventry (NPI) total score, Clinical Dementia Rating Scale, Barthel index, UPDRS, Self-Rating Scale of Sleep (SRSS), NCI-CTCAE, CIBIC-plus and SSA.
- Blood sample are obtained in order to investigate significant genes, proteins and metabolites involved in the development and progress of radiotherapy-related nervous system complications. Genomics, metabolomics and proteomics are performed to detect potential genes, proteins and metabolites. Stool sample are obtained in order to investigate interactions between the gut microbiota, immune and nervous systems in radiotherapy-related nervous system complications. Cerebrospinal fluid (CSF) and biopsy samples are obtained if needed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Years
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Radiotherapy is a key component in the management of head and neck tumors and primary or metastatic cancer of the central nervous system. The outcomes of various radiation protocols may be complicated by radiation effects on normal brain parenchyma and other nervous system, resulting in a spectrum of phenotypes that range from clinically asymptomatic changes to radiotherapy-related nervous system complications with severe neurological defects, including delayed radiation-induced brain necrosis, myelopathy and nerve injury.
Key inclusion criteria (1 listed)
- Receipt of radiotherapy
Key exclusion criteria (1 listed)
- Inability to sign a written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS)
Time frame: Baseline until death or up to Year 20
Overall survival is the duration between the first day of study enrollment to death. For participants who are alive, overall survival is censored at the last contact.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Derived from this study: PubMed 38908498Zuo X, Chen Y, Zhu Y, Pan D, Rong X, Shen Q, Li H, Xu Y, Tang Y. Radiation-induced Chronic Pain Plagues Head and Neck Cancer Survivors: A Cross-sectional Analysis From the Cohort in Radiotherapy-related Nervous System Complications. J Pain. 2024 Oct;25(10):104612. doi: 10.1016/j.jpain.2024.104612. Epub 2024 Jun 20.
- Derived from this study: PubMed 34650930Li H, Rong X, Hu W, Yang Y, Lei M, Wen W, Yue Z, Huang X, Chua MLK, Li Y, Cai J, He L, Pan D, Cheng J, Pi Y, Xue R, Xu Y, Tang Y. Bevacizumab Combined with Corticosteroids Does Not Improve the Clinical Outcome of Nasopharyngeal Carcinoma Patients With Radiation-Induced Brain Necrosis. Front Oncol. 2021 Sep 28;11:746941. doi: 10.3389/fonc.2021.746941. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yamei Tang, M.D., PhD. study director
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nervous System Complication, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yamei Tang, M.D., PhD. (86-13556001992, tangym@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Baseline until death or up to Year 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03908502, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.