- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05547971
Development of Intelligent Model for Radioactive Brain Damage of Nasopharyngeal Carcinoma Based on Radio-metabolomics
September 15, 2022 updated by: Xiangya Hospital of Central South University
This project focuses on the early prediction and diagnosis of radiation-induced brain injury in nasopharyngeal carcinoma patients.
Based on the big data of imaging and serum metabonomics samples, combined with the machine learning analysis method, dynamic evolution mode of radio-metabolomics characteristics was analyzed .
The potential internal relationship between brain structure and serum metabolic changes was explored, and the individualized prediction model was constructed to screen out the high-risk patients with brain injury after tumor radiotherapy, so as to provide reference for the diagnosis of radiation-induced brain injury caused by tumor.
radiotherapy Intelligent diagnosis provides a new theoretical and practical basis.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Research Process
- The MRI based cohort data set of nasopharyngeal carcinoma was established, and the data of multiple follow-up time points before and after radiotherapy (including initial diagnosis, 6 months, 12 months and 24 months after radiotherapy) were standardized to obtain the longitudinal data set;
- Region of interest (ROI): it mainly delineates the bilateral temporal lobe, brain stem and other brain regions, and extracts the corresponding image features in ROI;
- Feature selection: using the strategy of radiomics combined with Artificial Neural Network to reduce the dimension of high-dimensional image features, the key features are selected and used for the subsequent construction of classification and prediction model;
- Extracting key features: using vertical axis data analysis method and logistic regression to establish dynamic prediction model.
Study Type
Observational
Enrollment (Anticipated)
800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Weihua Liao, PHD
- Phone Number: 86-13973126486
- Email: ouwenliao@163.com
Study Contact Backup
- Name: Youming Zhang, MD
- Phone Number: 86-15974266761
- Email: fsknpcxm@163.com
Study Locations
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-
Hunan
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Changsha, Hunan, China, 410008
- Recruiting
- Xiangya Hospital of Central South University
-
Contact:
- Weihua Liao
- Phone Number: +8613973126486
- Email: ouwenliao@163.com
-
Contact:
- Youming Zhang
- Phone Number: +8615974266761
- Email: fsknpcxm@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Nasopharyngeal cancer patients in South University Xiangya Hospital, the First Affiliated Hospital of Nanhua University and the Affiliated Cancer Hospital of Central South University.
Description
Inclusion Criteria:
- Age 20-65; right handedness; Karnofsky physical condition score (KPS) ≥ 80;
- Histologically or cytologically confirmed non keratinizing squamous cell carcinoma of the nasopharynx with stage T3-4NxM0(AJCC 7th);
- Plan to receive intensity-modulated radiation therapy, the primary dose is more than or equal to 66Gy, fractional dose is less than 2.3Gy;
- Concurrent chemotherapy with cisplatin during radiotherapy, the total dose of chemotherapy is more than or equal to 200mg / m^2; 7. Primary school education or above, be able and willing to participate in the clinical trial, be able and willing to sign the agreement and consent, and be able and willing to record the symptoms and treatment details as often as necessary;
- White blood cell count ≥ 3 × 10^9 / L, neutrophil count ≥ 1.5 × 10^9 / L, hemoglobin ≥ 90g / L and platelet count ≥ 100 × 10^9 / L; ALT / AST ≤ 1.5 times of upper limit of normal (ULN), alkaline phosphatase (ALP) < 2.5 × ULN, bilirubin < ULN; ALB ≥ 28g / L;
- Patients can receive magnetic resonance imaging (MRI).
Exclusion Criteria:
- Unable or unwilling to give written and informed consent for MRI imaging, patients with claustrophobia, aneurysm clip, implantable nerve stimulator, implantable cardiac pacemaker or defibrillator, cochlear implant, eye foreign body or implant (such as metal chips, retinal clip) or pancreatic islet pump, and other contraindications for MRI scanning;
- He has a history of radiotherapy for the parts requiring radiotherapy in the past;
- There were no organic lesions in the brain, such as white matter lesions and brain atrophy, cerebrovascular diseases, brain tumors and brain trauma;
- Active, known or suspected autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, ulcerative colitis, Crohn's disease, myasthenia gravis, Hashimoto's thyroiditis, Graves' disease and asthma requiring bronchodilators. Subjects with type I diabetes, hypothyroidism requiring hormone replacement therapy only, and skin diseases (such as vitiligo, psoriasis, or alopecia) not requiring systemic therapy were included.
- Uncontrolled heart diseases, such as: (1) New York Heart Association classification grade 2 or above heart failure (2) unstable angina pectoris (3) myocardial infarction within one year (4) supraventricular or ventricular arrhythmias with clinical significance and requiring treatment or intervention.
- Pregnant or lactating women (for women with sexual life and fertility, pregnancy test should be considered);
- Previous or concurrent malignant tumors, except for non melanoma skin cancer, cervical carcinoma in situ and papillary thyroid cancer, which have recovered well after adequate treatment;
- Active infection requiring systemic treatment, positive for human immunodeficiency virus (HIV, HIV 1 / 2 antibody).
- A history of psychotropic drug abuse, alcoholism or drug abuse;
- Anti-vascular targeted drugs were used during induction chemotherapy before treatment;
- Other factors that may affect the safety of the subjects or the compliance of the test according to the judgment of the researcher. For example, serious diseases (including mental illness), serious laboratory abnormalities, or other family or social factors that need to be treated together. Currently or in the past, there are no major physical diseases, such as acute infection or untreated infection (viral, bacterial or fungal infection), heart disease, severe hypertension, diabetes, chronic kidney disease, genetic diseases, etc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Radiation Encephalopathy Group
Patients with radioactive encephalopathy during follow-up
|
The patients got intensity-modulated radiation therapy during observation
|
No Radiation Encephalopathy Group
Patients without radioactive encephalopathy during follow-up
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The patients got intensity-modulated radiation therapy during observation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The variations in imaging features from initial diagnosis to 24 months after radiotherapy
Time Frame: Before and after radiotherapy (including initial diagnosis, 6 months, 12 months and 24 months after radiotherapy). All the data got from each time point were used to conduct an efficient prediction model.
|
Brain MRI image data of included patients with MRI sequence (T1 Wi, T2 Wi, T1 + C etc.) before and after radiotherapy (including initial diagnosis, 6 months, 12 months and 24 months after radiotherapy) were obtained for Artificial Neural Network analysis.
The key features were found out by machine learning.The variations in imaging features from initial diagnosis to 24 months after radiotherapy were abtained to conduct an efficient prediction model for the probability of radiation encephalopathy.
|
Before and after radiotherapy (including initial diagnosis, 6 months, 12 months and 24 months after radiotherapy). All the data got from each time point were used to conduct an efficient prediction model.
|
Changes in metabolic feature from initial diagnosis to 24 months after radiotherapy
Time Frame: Before and after radiotherapy (including initial diagnosis, 6 months, 12 months and 24 months after radiotherapy). The PLS-DA model is used to represent changes in metabolic feature during metabolism.
|
Since the changes in serum nucleotide metabolism, amino acid metabolism, fat metabolism were observed in the radiation encephalopathy patients.
All Gas chromatography-mass spectrometer(GC-MS) data including retention features, peak intensity and integral mass spectrometry for each serum sample are used for analysis, to predict whether the separation between the radiation encephalopathy patients group and the control group is significant.
The serum metabolism changes of patients during two years after radiotherapy are followed to obtain metabolic footprint.
The serum sample got from different time points were applied in agglomerate hierarchical clustering for the screening and identification of various metabolites in the serum samples to get biomarkers, which can evaluate the changes of the metabolites in radiation encephalopathy.The PLS-DA model is used to represent changes in metabolic feature during metabolism.
|
Before and after radiotherapy (including initial diagnosis, 6 months, 12 months and 24 months after radiotherapy). The PLS-DA model is used to represent changes in metabolic feature during metabolism.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: fsknpcxm@163.com Liao, PHD, Xiangya Hospital of Central South University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2022
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
March 16, 2021
First Submitted That Met QC Criteria
September 15, 2022
First Posted (Actual)
September 21, 2022
Study Record Updates
Last Update Posted (Actual)
September 21, 2022
Last Update Submitted That Met QC Criteria
September 15, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Wounds and Injuries
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Brain Injuries
Other Study ID Numbers
- fskliaoweihua1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nasopharyngeal Carcinoma
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National Cancer Institute (NCI)NRG OncologyTerminatedRecurrent Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma AJCC v8 | Metastatic Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal Keratinizing Squamous Cell Carcinoma | Metastatic Nasopharyngeal Nonkeratinizing Carcinoma | Metastatic Nasopharyngeal Undifferentiated Carcinoma | Nasopharyngeal... and other conditionsUnited States, Canada, China, Singapore
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National Cancer Institute (NCI)CompletedRecurrent Nasopharynx Carcinoma | Stage III Nasopharyngeal Carcinoma AJCC v7 | Stage IV Nasopharyngeal Carcinoma AJCC v7 | Stage IVA Nasopharyngeal Carcinoma AJCC v7 | Stage IVB Nasopharyngeal Carcinoma AJCC v7 | Stage IVC Nasopharyngeal Carcinoma AJCC v7 | Nasopharyngeal Nonkeratinizing CarcinomaUnited States, Singapore, China
-
National Cancer Institute (NCI)Radiation Therapy Oncology GroupCompletedStage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7 | Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage III Nasopharyngeal...United States, Canada
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedStage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7 | Stage I Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage I Nasopharyngeal Undifferentiated Carcinoma AJCC v7 | Stage II Nasopharyngeal Keratinizing... and other conditionsUnited States, Canada, Australia
-
Alain AlgaziAstraZeneca; Incyte CorporationWithdrawnRecurrent Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma | Epstein-Barr Virus Positive | Stage III Nasopharyngeal Carcinoma | Stage IVA Nasopharyngeal Carcinoma | Stage IVB Nasopharyngeal Carcinoma
-
Alliance for Clinical Trials in OncologyNot yet recruitingRecurrent Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma AJCC v8 | Metastatic Nasopharyngeal Carcinoma
-
Gustave Roussy, Cancer Campus, Grand ParisUnknownLOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNTFrance
-
Stanford UniversityTerminatedStage IV Nasopharyngeal Carcinoma | Stage III Nasopharyngeal Carcinoma | Stage IVA Nasopharyngeal Carcinoma | Stage IVB Nasopharyngeal Carcinoma | Stage II Nasopharyngeal Carcinoma | Stage 0 Nasopharyngeal Carcinoma | Stage 0 Paranasal Sinus Cancer | Stage I Nasopharyngeal Carcinoma | Stage I Paranasal... and other conditionsUnited States
-
National Cancer Institute (NCI)Not yet recruitingStage IV Nasopharyngeal Carcinoma AJCC v8 | Stage II Nasopharyngeal Carcinoma AJCC v8 | Stage III Nasopharyngeal Carcinoma AJCC v8
-
National Cancer Institute (NCI)RecruitingRecurrent Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma AJCC v8 | Metastatic Nasopharyngeal CarcinomaUnited States, China
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National Cancer Institute (NCI)TerminatedLocally Recurrent Head and Neck Squamous Cell Carcinoma | Nasopharyngeal Squamous Cell Carcinoma | Sinonasal Squamous Cell CarcinomaUnited States
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NRG OncologyNational Cancer Institute (NCI)Active, not recruitingStage II Prostate AdenocarcinomaUnited States, Canada, Hong Kong, Switzerland, India, Ireland
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingRecurrent Head and Neck CarcinomaUnited States
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Institut Cancerologie de l'OuestCompletedCervical Cancer | Prostate Cancer | Anal Canal CancersFrance
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Memorial Sloan Kettering Cancer CenterCompletedMetastatic DiseaseUnited States
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University Health Network, TorontoOntario Cancer Research NetworkCompleted
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Alberta Health servicesCompleted
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Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)Active, not recruitingAnatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic Stage IIIA Breast Cancer AJCC v8 | Anatomic Stage IIIB Breast Cancer AJCC v8 | Anatomic Stage IIIC Breast Cancer AJCC... and other conditionsUnited States
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Royal Marsden NHS Foundation TrustUnknownProstate CancerUnited Kingdom