CClinicalTrials.gg
CompletedNCT05493930Updated Aug 9, 2022

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

An observational study in Rectum Cancer, sponsored by Peking Union Medical College. Completed. Per ClinicalTrials.gov, last updated 2022-08-09.

Sponsored by Peking Union Medical College · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
6,578
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's enrollment of 6,578 is above the median of 160 across 413 observational studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Peking Union Medical College is the lead sponsor of 58 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

rectal cancer patients with/without lymph node metastasis

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
6,578 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherThe hospital where the treatment is performed
06

What researchers measure

Primary outcomes

  1. diagnosis of lymph node metastasis

    The lymph node metastasis (LNM) status was determined based on the pathological diagnosis of the surgical specimens.

    Time frame: through study completion, an average of 1 month

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05493930
Lead sponsor
Peking Union Medical College
Collaborators
The Second Affiliated Hospital of Harbin Medical University, Changhai Hospital
Responsible party
Xishan Wang (Chief of Colorectal Cancer Surgery, Peking Union Medical College) — Principal investigator
First posted
Aug 9, 2022
Start date
Jan 1, 2010
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015
Last update
Aug 9, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion