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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05493930
Enrollment
6578
Registered
2022-08-09
Start date
2010-01-01
Completion date
2015-12-31
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectum Cancer

Brief 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.

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.

Interventions

OTHERThe hospital where the treatment is performed

Sponsors

The Second Affiliated Hospital of Harbin Medical University
CollaboratorOTHER
Changhai Hospital
CollaboratorOTHER
Peking Union Medical College
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
diagnosis of lymph node metastasisthrough study completion, an average of 1 monthThe lymph node metastasis (LNM) status was determined based on the pathological diagnosis of the surgical specimens.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026