Ignite Creation Date:
2024-05-06 @ 12:28 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03778255
Status:
UNKNOWN
Last Update Posted:
2018-12-19
First Post:
2018-12-13
Brief Title:
Sentinel Lymph Node Mapping In Endometrial Cancer
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
Comparing the Diagnostic Value of Different Lymph Node Tracing Methods in Detecting Sentinel Lymph Node Metastasis in Endometrial Cancer
Status:
UNKNOWN
Status Verified Date:
2018-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLNMIEC
Brief Summary:
Lymph node assessment provides the crucial information about the prognosis of endometrial cancer Sentinel lymph node stands in the first station on the lymph node metastasis pathways While traditional systemically lymph node resection would bring a lot of complications sentinel node mapping and biopsy is a feasible way with less damage to evaluate whether lymph node metastasis occurs in endometrial cancer patients due to less lymph nodes resected However the process of this technology in endometrial cancer isnt well established The investigators intend to conduct a prospective and multicentric study to evaluate the effectiveness of different mapping methods to achieve a reliable lymph node assessment Endometrial cancer patients in each center will be recruited in the investigators study with inclusion and exclusion criteria After the patients signing the informed consent form the surgery process will be performed including sentinel lymph node mapping with Carbon Nanoparticles CNP or CNP combining Indocyanine GreenICG hysterectomy with or without bilateral adnexectomy pelvic and para-aortic lymph node resection sequentially All resected nodes will be pathologically exanimated Then the data obtained will be analyzed and discussed deeply and finally lead to a conclusion
Detailed Description:
Quality Control The investigators quality assurance plan is as follows A Once the plan has been approved it cannot be modified at will If special circumstances such as difficulty in implementation are found after the start of the study the proposal may be revised or supplemented by the discussion of the research group and the project leader and the revised content shall be recorded in writing
The program change process is as follows
Identify the problems and understand the necessary to change the plan
Convene the main members of the research team and the project leader to discuss and propose solutions
Revise the plan and update the version number fill out the Program Description
The revised plan and the Revision of the Plan need to be signed by the person in charge of the project If necessary they must be submitted to the ethics committee for approval or filing if approved the revised plan can be implemented
B In order to ensure that the research personnel have sufficient qualifications to undertake specific research work the research personnel should at least complete the following training before the project starts
Research object protection and ethical requirements
Study protocols and related standard operating procedures tracer injection methods use of near-infrared fluorescent vascular imagers and pathology
Case Report Form and gauge filling instructions form entry criteria surgical record methods etc
Clinical research project implementation considerations such as research object screening enrollment data collection process Project-related training should be carried out throughout the research process The project leader and project coordinator can increase the training content according to the situation such as training on weak links in the test training on updating programs and various causes
Data Management A Case report form design The researcher is responsible for drafting the research case report form B Data Entry and Data Verification According to the final version of CRF the project database is built using software The data entry and verification is carried out by a dedicated person
Statistical Analysis A Statistical Analysis Plan and Statistical Software After the trial protocol is determined the statistical professors and the main investigators are responsible for developing a statistical analysis plan The statistical analysis software uses SAS 92 software software installation point authorization number 11202165
B Calculation and reasoning of sample size The sample size is calculated using PASS11 software the sample size is estimated based on the negative prediction value of the previous study and the negative prediction value of SLNs is expected to be 95 the allowable error is 2 the range of the confidence interval is 93 to 97 When the significant level is 005 508 cases are needed to be studied Considering the detection rate of 80 of SLNs a total of 635 cases are expected to be studied
C Statistical Analysis Methods General principle Using a two-sided test a P value of less than 005 would be considered statistically significant
The quantitative indicators will calculate the mean standard deviation median minimum maximum lower quartile Q1 upper quartile Q3 and the classification indicators will describe the number of cases and percentages
Comparison of clinicopathological features age body mass index pathological type tumor stage grading maximum tumor diameter invasive myometrial depth lymphatic vascular infiltration and tracer method for SLNs and undetected SLNs will be based on the type of indicator For the comparison of quantitative data between groups the t-test or Wilcoxon rank sum test will be used according to the data distribution For the comparison of categorical data between groups the data will be analyzed by chi-square test or exact probability method if the chi-square test is not applicable And the grade data was analyzed by Wilcoxon rank sum test or CMH test
Clinical diagnostic index calculation According to the true positive TP false negative FN true negative TN and false positive FP the results of SLNs pathological examination and all lymph node pathological examination results will be compared The comparison results will be plotted as a four-grid table to calculate sensitivity false negative rate and negative predictive value respectively
Chi-square test or exact probability method if the chi-square test is not applicable will be used to compare the clinical diagnosis value of SLNs biopsy of endometrial cancer patients with injection of carbon nanoparticles CNP or combined injection of CNP and indocyanine greenICG
Chi-square test or exact probability method if the chi-square test is not applicable will be used to analyze the clinic-pathological factors affecting the detection rate of SLNs
The program change process is as follows
Identify the problems and understand the necessary to change the plan
Convene the main members of the research team and the project leader to discuss and propose solutions
Revise the plan and update the version number fill out the Program Description
The revised plan and the Revision of the Plan need to be signed by the person in charge of the project If necessary they must be submitted to the ethics committee for approval or filing if approved the revised plan can be implemented
B In order to ensure that the research personnel have sufficient qualifications to undertake specific research work the research personnel should at least complete the following training before the project starts
Research object protection and ethical requirements
Study protocols and related standard operating procedures tracer injection methods use of near-infrared fluorescent vascular imagers and pathology
Case Report Form and gauge filling instructions form entry criteria surgical record methods etc
Clinical research project implementation considerations such as research object screening enrollment data collection process Project-related training should be carried out throughout the research process The project leader and project coordinator can increase the training content according to the situation such as training on weak links in the test training on updating programs and various causes
Data Management A Case report form design The researcher is responsible for drafting the research case report form B Data Entry and Data Verification According to the final version of CRF the project database is built using software The data entry and verification is carried out by a dedicated person
Statistical Analysis A Statistical Analysis Plan and Statistical Software After the trial protocol is determined the statistical professors and the main investigators are responsible for developing a statistical analysis plan The statistical analysis software uses SAS 92 software software installation point authorization number 11202165
B Calculation and reasoning of sample size The sample size is calculated using PASS11 software the sample size is estimated based on the negative prediction value of the previous study and the negative prediction value of SLNs is expected to be 95 the allowable error is 2 the range of the confidence interval is 93 to 97 When the significant level is 005 508 cases are needed to be studied Considering the detection rate of 80 of SLNs a total of 635 cases are expected to be studied
C Statistical Analysis Methods General principle Using a two-sided test a P value of less than 005 would be considered statistically significant
The quantitative indicators will calculate the mean standard deviation median minimum maximum lower quartile Q1 upper quartile Q3 and the classification indicators will describe the number of cases and percentages
Comparison of clinicopathological features age body mass index pathological type tumor stage grading maximum tumor diameter invasive myometrial depth lymphatic vascular infiltration and tracer method for SLNs and undetected SLNs will be based on the type of indicator For the comparison of quantitative data between groups the t-test or Wilcoxon rank sum test will be used according to the data distribution For the comparison of categorical data between groups the data will be analyzed by chi-square test or exact probability method if the chi-square test is not applicable And the grade data was analyzed by Wilcoxon rank sum test or CMH test
Clinical diagnostic index calculation According to the true positive TP false negative FN true negative TN and false positive FP the results of SLNs pathological examination and all lymph node pathological examination results will be compared The comparison results will be plotted as a four-grid table to calculate sensitivity false negative rate and negative predictive value respectively
Chi-square test or exact probability method if the chi-square test is not applicable will be used to compare the clinical diagnosis value of SLNs biopsy of endometrial cancer patients with injection of carbon nanoparticles CNP or combined injection of CNP and indocyanine greenICG
Chi-square test or exact probability method if the chi-square test is not applicable will be used to analyze the clinic-pathological factors affecting the detection rate of SLNs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None