Metastatic Lymph Node Distribution in the Ileum Mesentery of Cecal and Proximal Ascending Colon Cancer

NCT07149623 | Not Yet Recruiting DMC

• 1 other identifier: RELARC-02
• Study Type: observational
• Target: 406
• Locations: 0 countries
• Sites: N/A

Brief Summary

Based on the above considerations, our team maintains that it is currently imperative to conduct a prospective multicenter registry study. This study would involve sectioning and submitting fresh surgical specimens from the ileum mesentery of patients undergoing radical resection for cecal cancer and proximal ascending colon cancer (right-sided colon cancer). The objectives are to: Clarify the distribution range of metastatic lymph nodes within the ileum mesentery; Conduct survival follow-up on enrolled patients; Provide reliable evidence-based medical evidence for the individualized determination of ileal resection margins.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Metastatic rate in mesenteric lymph nodes

  1 month after surgery

Secondary Outcomes (3)

• Distribution of metastatic lymph nodes in the mesentery

  1 month after surgery

• 3-year disease-free survival

  3 years after surgery

• 5-year overall survival

  5 years after surgery

Study Arms (1)

experimental group

Procedure: Experimental

Interventions

Experimental PROCEDURE

sectioning and submitting fresh surgical specimens from the ileum mesentery

experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with cecal cancer and proximal ascending colon cancer

You may qualify if:

• Age 18-80 years; ECOG performance status 0-2; Histologically confirmed colon adenocarcinoma; Surgical specimen confirming tumor location at: ileocecal valve orifice (cecal cancer), OR proximal ascending colon cancer with tumor ≤5 cm from ileocecal valve; Clinical stage: cT2-4aN0M0, OR cTanyN+M0; Patient and family members fully understand the study and voluntarily participate by signing informed consent

You may not qualify if:

• Synchronous or metachronous multiple primary colon cancers (Note: Synchronous: diagnosed within 6 months; Metachronous: diagnosed \>6 months apart); Preoperative neoadjuvant therapy (chemotherapy, immunotherapy, or radiotherapy) that may cause tumor regression or downstaging; Patients undergoing salvage radical surgery after endoscopic resection.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Zhen Sun

CONTACT

86-18910598831; sunzhen39@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: XIAO Yi

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: September 2, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2030
• Last Updated: September 2, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share