NCT06135571

Brief Summary

The goal of this observational study is to learn about the the pattern of metastasis of the No.253 lymph node in colorectal cancer. The main questions it aims to answer are: 1. What are the risk factors for metastasis to the No.253 lymph node? 2.What is the prognosis for patients with metastasis to the No.253 lymph node? Patients with descending colon cancer, sigmoid colon cancer, and rectal cancer who undergo curative surgery with dissection of the No.253 lymph node are included in this study

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
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

Study Progress89%
Sep 2023Sep 2026

Study Start

First participant enrolled

September 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 12, 2023

Last Update Submit

November 16, 2023

Conditions

Colorectal CancerLymph Node Metastasis

Keywords

Left-sided colorectal cancerLymph node dissectionNo.253 lymph node

Outcome Measures

Primary Outcomes (1)

  • Metastatic rate of No.253 lymph node

    Pathologically confirmed tumor cell infiltration in the No.253 lymph node

    About 10 days after surgery

Secondary Outcomes (5)

  • Number of harvested lymph nodes

    About 10 days after surgery

  • Incidence of postoperative complications

    30 days after surgery

  • 5-year local recurrence rate

    5 years after surgery

  • 5-year disease free survival rate

    5 years after surgery

  • 5-year overall survival rate

    5 years after surgery

Study Arms (1)

Cohort of left-sided colorectal cancer

Patients underwent curative surgery with dissection of No.253 Lymph node

Procedure: Laparoscopic colorectal surgery

Interventions

Laparoscopic colorectal surgeryPROCEDURE

Patients underwent laparoscopic left colectomy, sigmoid resection or rectal surgery according to the location of tumor.

Cohort of left-sided colorectal cancer

Eligibility Criteria

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

Patients with left-sided colorectal cancer (left colon cancer, sigmoid cancer, rectal cancer) underwent laparoscopic surgery with dissection of No.253 lymph node.

You may qualify if:

  • Age: 18-75 years;
  • Underwent laparoscopic left hemicolectomy, sigmoid colectomy, or rectal cancer radical surgery.
  • Postoperative pathology confirmed as adenocarcinoma.
  • No evidence of distant metastasis.

You may not qualify if:

  • Previous history of malignant colorectal tumors.
  • Patients who have undergone multiple abdominal-pelvic surgeries.
  • Patients undergoing emergency surgery due to complications such as intestinal obstruction, intestinal perforation, or intestinal bleeding.
  • Surgery did not achieve R0 resection.
  • Patients with concurrent other malignant tumors or multiple primary colorectal cancers.
  • Patients unwilling to sign an informed consent or follow the study protocol for follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100021, China

RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Chinese PLA General Hospital

Beijing, Beijng, 100141, China

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsLymphatic Metastasis

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Qian Liu, Dr.

CONTACT

13601008906fcwpumch@163.com

Mingguang Zhang, Dr.

CONTACT

+8613261967603zmgslimshady@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 12, 2023

First Posted

November 18, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion (Estimated)

September 1, 2026

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)