Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572592
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
The Predictive Value of MRI for Adult-type Diffuse Gliomas
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Prognostic Value of Preoperative Multi-model Diffusion MRI in Predicting Ki-67 Proliferation for Adult-type Diffuse Gliomas
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MRI glioma
Brief Summary:
The goal of this observational study is to learn about the diagnostic value of preoperative MRI examination for adult-type diffuse gliomas The main question it aims to answer is
Can preoperative MRI examination noninvasively predict genotype of gliomas
Can preoperative MRI examination noninvasively predict the overall survival of gliomas
Can preoperative MRI examination noninvasively predict Ki-67 proliferation status
Can preoperative MRI examination noninvasively predict genotype of gliomas
Can preoperative MRI examination noninvasively predict the overall survival of gliomas
Can preoperative MRI examination noninvasively predict Ki-67 proliferation status
Detailed Description:
Method for Determining the Required Sample Size
This study is observational and involves no intervention Therefore the sample size was estimated using the following formula
where N is the sample size Uα is the value of υ corresponding to the test level α S is the overall standard deviation and δ is the allowable error
Since the specific value of δ could not be known in advance the study referred to the literature and identified three widely accepted methods for estimating δ Method ① Conduct a pre-experiment before the study begins using the inter-group difference as the δ value directly Method ② Consult relevant authorities in advance to determine a professionally meaningful δ value Method ③ In the absence of pre-experiment results and expert opinions it is permissible to use 025 or 050 times the standard deviation as δ According to the allowable error δ reference flowchart by Ni Yanyan and Zhang Jinxin this study used method ③ to determine δ Therefore at α 005 the minimum sample size N can range from 16 to 62 cases Considering a loss-to-follow-up rate of 15-20 the sample size can be expanded to 19-78 cases Finally considering that Logistic regression analysis will be used in statistical analysis with 15 quantitative indicators as independent variables the estimated sample size should be at least 150 cases Taking into account factors such as economy and time the sample size for this study is determined to be 150-200 cases
Research Content
The collection of glioma patients is divided into two parts the first part is a retrospective study based on already collected glioma patients and the second part is a prospective collection of glioma patients detailed as follows
First Part Retrospectively collect glioma patients who visited our hospital from May 1 2014 to December 31 2024 according to the inclusion criteria
Second Part Prospectively collect glioma patients who visited our hospital from January 1 2021 to December 31 2022 according to the inclusion criteria Furthermore track obtain and analyze tumor specimens from the enrolled glioma patients conducting tumor grade analysis and detecting major molecular gene mutation status related to prognosis including IDH 1p19q TERT ATRX EGFR amplification 710- etc By using quantitative qualitative radiomics and machine learning methods to analyze multiparametric MRI data of glioma patients statistical analysis and modeling will be performed to establish a model based on multiparametric MRI for predicting glioma grade and prognosis-related molecular mutation status
Survey Content The outcome indicators are glioma grade and prognosis-related molecular mutation status which will be tested by the pathology department personnel The exposure factor is the quantitative analysis data from multiparametric MRI examinations and potential confounding factors are the age and sex of the subjects these indicators will be searched measured and recorded by specialized personnel in the medical system
Data Management and Statistical Analysis Plan Data Management Use EXCEL software to establish an electronic spreadsheet with specialized personnel manually inputting data such as general information replaced by patient numbers age sex etc multiparametric MRI examination data such as Ktrans values obtained after DCE-MRI post-processing and pathological data such as tumor grade and classification different molecular mutation statuses etc saving and archiving data in real-time
Statistical Analysis Use SPSS 250 statistical analysis software for data analysis For quantitative data such as Ktrans values obtained after DCE-MRI post-processing perform normality tests with S-W and Levenes tests Data that is normally distributed is expressed as mean standard deviation and non-normally distributed data is expressed as M P25 P75 Prognosis-related molecular mutation status such as IDH mutation is dichotomous data with mutations deletions or amplifications
Bias Control Bias that is prone to occur in this observational study is information bias The main research steps where bias is likely to occur and the control methods are as follows ① Acquisition process of multiparametric MRI quantitative data The control method involves establishing uniform measurement standards before analysis and adhering strictly to these standards measuring multiple tumor areas and taking the average result as the final result and ensuring that the measurements are conducted by the same person throughout ② Data entry process The control method involves timely review of each data item during data collection and randomly selecting some data for double entry to check the quality of data entry ③ Pathology The control method involves classifying according to the 2016 WHO new classification standards for glioma and attempting to control the detection of molecular mutation status to be done by the same person using the same batch of test reagents at the same time In addition to this factors such as age and sex may be confounding variables that can cause confounding bias The control method involves collecting patients age sex etc during the data collection process and using multivariate statistical analysis methods stratified analysis methods etc to control bias during statistical analysis
Quality Management The entire research process is carried out according to the experimental plan with particular attention to controlling bias The quality of the study is evaluated based on the quality evaluation criteria recommended by the Agency for Healthcare Research and Quality AHRQ The criteria include 11 items which are answered with yes no or unclear 1 Is the source of the data survey literature review clearly stated 2 Are the inclusion and exclusion criteria for the exposed and non-exposed groups cases and controls listed or are previous publications referenced 3 Is the time frame for identifying patients provided 4 If not from a population source is the study population continuous 5 Do the subjective factors of the evaluator obscure other aspects of the study subjects 6 Is any assessment described that was done to ensure quality eg testingretesting of primary outcome indicators 7 Is the reason for excluding any patients from the analysis explained 8 Are the measures for evaluating andor controlling confounding factors described 9 If possible is the handling of missing data in the analysis explained 10 Is the patient response rate and the completeness of data collection summarized 11 If there is follow-up is the percentage of expected incomplete data or follow-up results identified The observational study report is written in the format of the STROBE the Strengthening the Reporting of Safety Evaluation The main content of this study involves the secondary use of medical records imaging data and biological specimens posing almost no risk to the participants
Ethical Review and Informed Consent This study complies with medical ethical standards and has applied for ethical approval from the Ethics Committee of the First Affiliated Hospital of Sun Yat-sen University For the prospective study part informed consent will be obtained from the participants and an informed consent form will be signed The study will strictly adhere to the rules of patient information confidentiality not recording patient names and distinguishing cases by image number or examination number The participants multiparametric MRI data examination and analysis are non-invasive involving only the extraction and analysis of image data with the participants personal information kept confidential throughout Subsequent tumor sample analysis is based on specimens already obtained from surgical resection or biopsy hence there is no additional risk in sample collection During the study the main molecular mutation status related to prognosis in the participants tumor samples will be analyzed This information will be beneficial for the clinical diagnosis treatment and prognosis assessment of cancer from which the participants will benefit
This study is observational and involves no intervention Therefore the sample size was estimated using the following formula
where N is the sample size Uα is the value of υ corresponding to the test level α S is the overall standard deviation and δ is the allowable error
Since the specific value of δ could not be known in advance the study referred to the literature and identified three widely accepted methods for estimating δ Method ① Conduct a pre-experiment before the study begins using the inter-group difference as the δ value directly Method ② Consult relevant authorities in advance to determine a professionally meaningful δ value Method ③ In the absence of pre-experiment results and expert opinions it is permissible to use 025 or 050 times the standard deviation as δ According to the allowable error δ reference flowchart by Ni Yanyan and Zhang Jinxin this study used method ③ to determine δ Therefore at α 005 the minimum sample size N can range from 16 to 62 cases Considering a loss-to-follow-up rate of 15-20 the sample size can be expanded to 19-78 cases Finally considering that Logistic regression analysis will be used in statistical analysis with 15 quantitative indicators as independent variables the estimated sample size should be at least 150 cases Taking into account factors such as economy and time the sample size for this study is determined to be 150-200 cases
Research Content
The collection of glioma patients is divided into two parts the first part is a retrospective study based on already collected glioma patients and the second part is a prospective collection of glioma patients detailed as follows
First Part Retrospectively collect glioma patients who visited our hospital from May 1 2014 to December 31 2024 according to the inclusion criteria
Second Part Prospectively collect glioma patients who visited our hospital from January 1 2021 to December 31 2022 according to the inclusion criteria Furthermore track obtain and analyze tumor specimens from the enrolled glioma patients conducting tumor grade analysis and detecting major molecular gene mutation status related to prognosis including IDH 1p19q TERT ATRX EGFR amplification 710- etc By using quantitative qualitative radiomics and machine learning methods to analyze multiparametric MRI data of glioma patients statistical analysis and modeling will be performed to establish a model based on multiparametric MRI for predicting glioma grade and prognosis-related molecular mutation status
Survey Content The outcome indicators are glioma grade and prognosis-related molecular mutation status which will be tested by the pathology department personnel The exposure factor is the quantitative analysis data from multiparametric MRI examinations and potential confounding factors are the age and sex of the subjects these indicators will be searched measured and recorded by specialized personnel in the medical system
Data Management and Statistical Analysis Plan Data Management Use EXCEL software to establish an electronic spreadsheet with specialized personnel manually inputting data such as general information replaced by patient numbers age sex etc multiparametric MRI examination data such as Ktrans values obtained after DCE-MRI post-processing and pathological data such as tumor grade and classification different molecular mutation statuses etc saving and archiving data in real-time
Statistical Analysis Use SPSS 250 statistical analysis software for data analysis For quantitative data such as Ktrans values obtained after DCE-MRI post-processing perform normality tests with S-W and Levenes tests Data that is normally distributed is expressed as mean standard deviation and non-normally distributed data is expressed as M P25 P75 Prognosis-related molecular mutation status such as IDH mutation is dichotomous data with mutations deletions or amplifications
Bias Control Bias that is prone to occur in this observational study is information bias The main research steps where bias is likely to occur and the control methods are as follows ① Acquisition process of multiparametric MRI quantitative data The control method involves establishing uniform measurement standards before analysis and adhering strictly to these standards measuring multiple tumor areas and taking the average result as the final result and ensuring that the measurements are conducted by the same person throughout ② Data entry process The control method involves timely review of each data item during data collection and randomly selecting some data for double entry to check the quality of data entry ③ Pathology The control method involves classifying according to the 2016 WHO new classification standards for glioma and attempting to control the detection of molecular mutation status to be done by the same person using the same batch of test reagents at the same time In addition to this factors such as age and sex may be confounding variables that can cause confounding bias The control method involves collecting patients age sex etc during the data collection process and using multivariate statistical analysis methods stratified analysis methods etc to control bias during statistical analysis
Quality Management The entire research process is carried out according to the experimental plan with particular attention to controlling bias The quality of the study is evaluated based on the quality evaluation criteria recommended by the Agency for Healthcare Research and Quality AHRQ The criteria include 11 items which are answered with yes no or unclear 1 Is the source of the data survey literature review clearly stated 2 Are the inclusion and exclusion criteria for the exposed and non-exposed groups cases and controls listed or are previous publications referenced 3 Is the time frame for identifying patients provided 4 If not from a population source is the study population continuous 5 Do the subjective factors of the evaluator obscure other aspects of the study subjects 6 Is any assessment described that was done to ensure quality eg testingretesting of primary outcome indicators 7 Is the reason for excluding any patients from the analysis explained 8 Are the measures for evaluating andor controlling confounding factors described 9 If possible is the handling of missing data in the analysis explained 10 Is the patient response rate and the completeness of data collection summarized 11 If there is follow-up is the percentage of expected incomplete data or follow-up results identified The observational study report is written in the format of the STROBE the Strengthening the Reporting of Safety Evaluation The main content of this study involves the secondary use of medical records imaging data and biological specimens posing almost no risk to the participants
Ethical Review and Informed Consent This study complies with medical ethical standards and has applied for ethical approval from the Ethics Committee of the First Affiliated Hospital of Sun Yat-sen University For the prospective study part informed consent will be obtained from the participants and an informed consent form will be signed The study will strictly adhere to the rules of patient information confidentiality not recording patient names and distinguishing cases by image number or examination number The participants multiparametric MRI data examination and analysis are non-invasive involving only the extraction and analysis of image data with the participants personal information kept confidential throughout Subsequent tumor sample analysis is based on specimens already obtained from surgical resection or biopsy hence there is no additional risk in sample collection During the study the main molecular mutation status related to prognosis in the participants tumor samples will be analyzed This information will be beneficial for the clinical diagnosis treatment and prognosis assessment of cancer from which the participants will benefit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None