NCT05859581

Brief Summary

The goal of this clinical trial is to explore the value of colon MRI in assessing the status of retroperitoneal resection margin (RPRM) for advanced colon cancer. The main questions it aims to answer are:

  • Concordance between MRI suspected RPRM positive and pathologically confirmed positive.
  • Can RPRM-positive patients undergo beyond complete mesocolic excision (CME) surgery in order to achieve R0 resection? Participants will undergo colon MRI examination and once MRI suspects RPRM positive, they will receive beyond CME surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

April 2, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

May 5, 2023

Last Update Submit

May 5, 2023

Conditions

Colon Cancer

Keywords

Colon cancerMRIResection margin

Outcome Measures

Primary Outcomes (1)

  • Coincidence rate with pathological result

    Coincidence rate between MRI diagnosed retroperitoneal resection margin and pathologically confirmed positive

    within 2 weeks after surgery

Study Arms (1)

Suspected positive RPRM on MRI

EXPERIMENTAL
Procedure: Beyond complete mesocolic excision surgery

Interventions

Beyond complete mesocolic excision surgeryPROCEDURE

If the participants were diagnosed with positive retroperitoneal resection margin (RPRM), they underwent beyond complete mesocolic excision surgery to ensure the R0 resection.

Suspected positive RPRM on MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary colon adenocarcinoma confirmed by biopsy
  • preoperative CT suspecting retroperitoneal resection margin (RPRM) positive
  • received colon MRI scan
  • underwent beyond complete mesocolic excision surgery
  • sufficient clinical and pathological results

You may not qualify if:

  • combined with other malignant tumors
  • simultaneous distant metastasis
  • definite invaded other organs or structures (T4b tumors)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Colonic NeoplasmsMargins of Excision

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesMorphological and Microscopic FindingsPathological Conditions, Signs and Symptoms

Study Officials

  • Ying-Shi Sun, MD

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen Guan, MD

CONTACT

86108819682518801231091@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 16, 2023

Study Start

April 2, 2023

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)