Sentinel Lymph Node Mapping In Endometrial Cancer (SLNMIEC)

December 15, 2018 updated by: Peking University People's Hospital

Comparing the Diagnostic Value of Different Lymph Node Tracing Methods in Detecting Sentinel Lymph Node Metastasis in Endometrial Cancer

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 isn't 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 Green(ICG), 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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® 9.2 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 0.05, 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 0.05 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 green(ICG).

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 Type

Interventional

Enrollment (Anticipated)

635

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hosoital
        • Sub-Investigator:
          • Zhiqi Wang, Professor
        • Principal Investigator:
          • Xiaoping Wang, Professor

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosis of endometrial cancer (including all pathological type and clinical stage).
  • Decide to receive hysterectomy with or without bilateral adnexectomy, pelvic and para-aortic lymph node resection
  • Agree to conduct the study and sign an informed consent form

Exclusion Criteria:

  • History of previous pelvic or inguinal lymphadenectomy or other history of surgery affecting the uterine lymphatic drainage
  • Other history of pelvic or abdominal malignant tumors in the past 5 years
  • Intolerable for surgery due to severe comorbidities
  • During a period of pregnancy
  • Allergic to the tracer
  • Diagnosis of uncontrolled epilepsy, central nervous system disease or mental disorder, with the judgment from the investigator that the above diseases would affect clinical research compliance.

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Undergoing sentinel lymph node biopsy
Procedure: Sentinel Lymph Node Biopsy
  1. Injecting carbon nanoparticles (CNP)[Not Equipped with near-infrared fluorescent vascular imager] or CNP combining Indocyanine Green(ICG)[Equipped with near-infrared fluorescent vascular imager].
  2. Identifying and removing sentinel lymph nodes.
  3. Staining all nodes using hematoxylin-eosin staining.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative predictive value
Time Frame: Through study completion, an average of 2 years
Sentinel lymph node detection is defined as at least one lymph node is found in a patient. Sentinel lymph node negative is defined as no sentinel lymph node detected. True negative is defined as no metastasis found in both sentinel lymph nodes (SLNs) and non-SLNs. Negative predictive value is defined as the proportion of true negative patients to SLNs negative patients in patients with sentinel lymph nodes detected, which means patients without SLNs detected won't be included in the calculation.
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: Through study completion, an average of 2 years
Sensitivity is defined as the proportion of the SLNs positive patients in patients with SLNs or non-SLNs lymphatic metastasis (among the patients with SLNs detected)
Through study completion, an average of 2 years
False negative rate
Time Frame: Through study completion, an average of 2 years
False negative is defined as no metastasis found in SLNs while metastasis found in non-SLNs. False negative rate is defined as the proportion of the false negative patients in the patients with SLNs or non-SLNs lymphatic metastasis(among the patients with SLNs detected)
Through study completion, an average of 2 years
detection rate
Time Frame: Through study completion, an average of 2 years
Sentinel lymph node detection is defined as at least one lymph node is found in a patient. The detection rate is the proportion of the patients with SLNs detected in all enrolled patients.
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

Sun Yat-sen University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Peking University International Hospital
The First Affiliated Hospital of Zhengzhou University
Second Affiliated Hospital of Zhengzhou University
First People's Hospital of Foshan
Obstetrics & Gynecology Hospital of Fudan University
Shanghai First Maternity and Infant Hospital
Cancer Hospital of Guangxi Medical University
Tianjin Central Hospital of Gynecology Obstetrics
Beijing Blue Sky Shared Health Management Co., Ltd.
Chongqing Lummy Pharmaceutical Co.,Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 15, 2018

Primary Completion (ANTICIPATED)

June 30, 2020

Study Completion (ANTICIPATED)

June 30, 2020

Study Registration Dates

First Submitted

December 13, 2018

First Submitted That Met QC Criteria

December 15, 2018

First Posted (ACTUAL)

December 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 15, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018PHD002-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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