NCT06319404

Brief Summary

Lymph nodes are very important immune organs in the human body and play an important role in the physiological and pathological activities of the body, especially in anti-tumor immunity. The role of regional draining lymph nodes in the development of colorectal cancer is still unknown. In this study, the role of lymph nodes in the development of colorectal cancer was investigated through multicenter and multi-omics data.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 20, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

January 19, 2024

Last Update Submit

March 12, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • To investigate the difference of immune pathway activation in tumor-draining lymph node based on genomics

    BULK-RNA sequencing was performed on tumor draining lymph nodes to detect the activation of immune pathways in lymph nodes and explore the differences between them

    2024.04-2026.04

  • To investigate the relationship between the type and number of immune cells in tumor draining lymph nodes and the activation of immune pathways is based on pathomics

    Multiple immunohistochemistry was used to identify the type and number of immune cells and to explore the relationship between the activation state of immune pathways

    2024.04-2026.04

  • The immune function of tumor draining lymph nodes of colorectal cancer patients was previously identified based on radiomics

    Preoperative imaging data (CT, MRI) of patients were collected, and information in the images was extracted based on artificial intelligence algorithms. Predictive models were constructed to identify patients with good or bad immune function before surgery and guide subsequent treatment

    2024.04-2026.04

Study Arms (2)

negative lymph node

postive lymph node

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stage I-III colorectal cancer patients undergoing radical surgery with complete clinical imaging, pathology, and genetic data.

You may qualify if:

  • Stage I-III colorectal cancer patients undergoing radical surgery
  • Complete imaging, pathology and genetics multi-omics data available
  • years old

You may not qualify if:

  • Patients with preoperative neoadjuvant therapy
  • Patients with incomplete clinical information
  • Patients with other malignant tumors
  • Patients with acute infections or untreated chronic infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2024

First Posted

March 20, 2024

Study Start

April 1, 2024

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

March 20, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share