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A multicenter cohort study on predicting lymph node metastasis risk in T1 colorectal cancer based on AI big data algorithms and multimodal clinical features

A multicenter cohort study on predicting lymph node metastasis risk in T1 colorectal cancer based on AI big data algorithms and multimodal clinical features

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113880
Enrollment
Unknown
Registered
2025-12-04
Start date
2025-08-15
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

T1 colorectal cancer

Interventions

T1 colorectal cancer cohort:None

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients with colorectal adenocarcinoma confirmed by histology or cytology at initial diagnosis; 2.Patients with colorectal cancer (CRC) who were initially considered to be in stage T1, underwent additional radical surgery after initial endoscopic resection, and were confirmed to be in stage T1 by postoperative pathology; 3.Having relatively complete preoperative laboratory tests, including blood routine, liver and kidney function, tumor markers, and coagulation indicators, etc. 4.Having pathological results after endoscopic resection; 5.Having relatively complete preoperative examinations, including X-ray, abdominal ultrasound, chest-abdomen-pelvis CT, and rectal MRI, etc. 6.Age equal to or greater than 18 years old; 7.Eastern Cooperative Oncology Group (ECOG) performance status score <= 2; 8. All surgeries follow the principles of total mesorectal excision (TME) or complete mesocolic excision (CME). Surgical methods include traditional open surgery, laparoscopic-assisted radical CRC surgery, and totally laparoscopic radical CRC surgery; 9. Patients agree to provide clinical diagnosis and treatment information and may participate in research visits, laboratory tests, and other research procedures.

Exclusion criteria

Exclusion criteria: 1.Received neoadjuvant chemotherapy or radiotherapy before the operation; 2.There is a serious lack of clinical information; 3.Primary malignant tumors with distant metastasis or combined with other organs; 4.The postoperative tumor pathological type is a malignant tumor of non-glandular epithelial cell origin, such as neuroendocrine tumors, squamous cell carcinoma, melanoma, stromal tumor and lymphoma, etc; 5.Surgical specimens infiltrate into the muscularis propria or deeper; 6.The clinical diagnosis is familial adenomatous polyposis (FAP), Lynch syndrome or inflammatory bowel disease (IBD); 7.Patients with severe organic lesions of the heart, kidneys, brain, lungs and other organs; 8.Unwillingness or inability to comply with the research protocol, and missing case data;

Design outcomes

Primary

MeasureTime frame
All kinds of examination images and results;

Secondary

MeasureTime frame
Various laboratory test results;

Countries

China

Contacts

Public ContactJing Sun

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

sj11788@rjh.com.cn+86 13524284622

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026