The Value of MRI in Assessing the Status of Retroperitone... | NCT05859581

Studies
The Value of MRI in Assessing the Status of Retroperitoneal Resection Margin in Colon Cancer

NCT05859581

Sponsor

Peking University Cancer Hospital & Institute

Status

Unknown status

Last Update Posted

May 16, 2023Actual

Enrollment

29Estimated

Phase

Not Applicable

Conditions

Colon Cancer

Interventions

Beyond complete mesocolic excision surgery

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2, 2023Actual

Primary Completion Date

Aug 31, 2023Estimated

Completion Date

Aug 31, 2023Estimated

First Submitted Date

May 5, 2023

First Submission Date that Met QC Criteria

May 5, 2023

First Posted Date

May 16, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2023

Last Update Posted Date

May 16, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Suspected positive RPRM on MRI	Experimental		Procedure: Beyond complete mesocolic excision surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Beyond complete mesocolic excision surgery	Procedure	If the participants were diagnosed with positive retroperitoneal resection margin (RPRM), they underwent beyond complete mesocolic excision surgery to ensure the R0 resection.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Coincidence rate with pathological result	Coincidence rate between MRI diagnosed retroperitoneal resection margin and pathologically confirmed positive	within 2 weeks after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhen Guan, MD	Contact	861088196825		18801231091@163.com

Overall Officials

Name	Affiliation	Role
Ying-Shi Sun, MD	Peking University Cancer Hospital & Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Cancer Hospital	Recruiting	Beijing	Beijing Municipality	100142	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms
D000072662	Margins of Excision

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided