A Lymph Node Metastasis Predictor (LN-MASTER) in Rectal Cancer

An Easy-to-use Artificial Intelligence Preoperative Lymph Node Metastasis Predictor (LN-MASTER) in Rectal Cancer Based on a Privacy-preserving Computing Platform: Multicenter Retrospective Cohort Study

In this study, we aim to develop and validate an easy-to-use machine learning prediction model to preoperatively identify the lymph node metastasis status for rectal cancer patients by using these clinical data from three hospitals.

Study Overview

• Status: Completed
• Conditions: Rectum Cancer
• Intervention / Treatment: Other: The hospital where the treatment is performed

Detailed Description

In this study, participants were recruited from the Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College (development set), Changhai Hospital, Naval Medical University (external validation set 1), and the Second Affiliated Hospital of Harbin Medical University (external validation set 2), between January 1, 2016, and December 31, 2020. According to the inclusion criteria, participants who (a) were in American Joint Committee on Cancer (AJCC) stages I -III rectal cancer and (b) underwent radical surgery were recruited. In contrast, the exclusion criteria were as follows: (a) other malignancies, (b) received treatment with endoscopic submucosal dissection (ESD), (c) metastatic lesions, (d) did not undergo lymph node dissection, (e) had unavailable assessed lymph node status, and (f) received neoadjuvant therapy. The lymph node metastasis (LNM) status was determined based on the pathological diagnosis of the surgical specimens.

Clinicopathological features included sex, age, body mass index (BMI), comorbidity, distance from the lower edge of the tumor to the anus, carcinoembryonic antigen (CEA) levels, carbohydrate antigen 19-9 (CA19-9) levels, tumor size, degree of tumor differentiation, tumor histology, vascular or lymphatic vessel invasion, AJCC T stage, clinical diagnosis of LNM, and the pathological diagnosis of LNM. Among these, sex, age, BMI, and comorbidities of each participant, such as diabetes, hypertension, hyperlipidemia, and other chronic systemic diseases, were extracted from the electronic hospital information system. Preoperative CEA and CA19-9 levels were obtained from hematological examinations at the time of rectal cancer diagnosis. The distance from the lower edge of the tumor to the anus, differentiation degree, and tumor histology were recorded based on the results of endoscopy and endoscopic biopsies. The tumor diameter and clinical diagnosis of LNM were defined using preoperative pelvic MRI or CT. The diagnosis of vascular invasion, lymphatic vessel invasion, and LNM was based on postoperative pathological diagnosis.

• Study Type: Observational
• Enrollment (Actual): 6578

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

rectal cancer patients with/without lymph node metastasis

Description

Inclusion Criteria:

• American Joint Committee on Cancer (AJCC) stages I -III rectal cancer
• underwent radical surgery

Exclusion Criteria:

• other malignancies
• received treatment with endoscopic submucosal dissection (ESD)
• metastatic lesions
• did not undergo lymph node dissection
• had unavailable assessed lymph node status
• received neoadjuvant therapy

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
development set; RC patients from the Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College	Other: The hospital where the treatment is performed
external validation sets 1; RC patients from Changhai Hospital, Naval Medical University	Other: The hospital where the treatment is performed
external validation sets 2; RC patients from the Second Affiliated Hospital of Harbin Medical University	Other: The hospital where the treatment is performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnosis of lymph node metastasis	The lymph node metastasis (LNM) status was determined based on the pathological diagnosis of the surgical specimens.	through study completion, an average of 1 month

Collaborators and Investigators

• Sponsor: Peking Union Medical College
• Collaborators: Changhai Hospital; The Second Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2010
• Primary Completion (ACTUAL): December 31, 2015
• Study Completion (ACTUAL): December 31, 2015

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 6, 2022
• First Posted (ACTUAL): August 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 6, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis; Rectal Neoplasms; Lymphatic Metastasis
• Other Study ID Numbers: XWANG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No