Non-microradical Resection Margin as a Predictor for Recu... | NCT04395534

Studies
Non-microradical Resection Margin as a Predictor for Recurrence After Complete Mesocolic Excision

NCT04395534

Sponsor

Claus Anders Bertelsen, PhD, MD

Status

Completed

Last Update Posted

May 20, 2020Actual

Enrollment

276Actual

Phase

Not provided

Conditions

Colon Cancer

Interventions

Complete mesocolic excision

Countries

Not provided

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 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2008Actual

Primary Completion Date

Mar 15, 2020Actual

Completion Date

Mar 15, 2020Actual

First Submitted Date

May 15, 2020

First Submission Date that Met QC Criteria

May 15, 2020

First Posted Date

May 20, 2020Actual

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 15, 2020

Last Update Posted Date

May 20, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claus Anders Bertelsen, PhD, MD, Consultant Colorectal Surgeon, Associate Professor, Head of Research Department of Surgery, Nordsjaellands HospitalSponsor-Investigator

Lead Sponsor

Claus Anders Bertelsen, PhD, MDOTHER

Collaborators

Not provided

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 study aim to investigate the value of the current definition of microradical resection margin in colon cancer. Is the distance from tumor tissue to resection margin and the site of any clinically prognostic importance if complete mesocolic excision has been performed.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

276Actual

Name	Type	Description	Arm Group Labels	Other Names
Complete mesocolic excision	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence	Any type of recurrence	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Undergoing elective curative intended complete mesocolic excision for primary colon adenocarcinoma at Nordsjællands Hospital in Hillerød, Denmark
International Union Against Cancer (Union Internationale Contre le Cancer - UICC) stage III - pT1-4, pN1-2 cM0 (gastroepiploic and infrapyloric lymph node metastases are not considered as distant metastases)
Resident in Denmark at the time of surgery.

Exclusion Criteria:

Patients who did not undergo macroradical resections
Synchronous colorectal cancer
Venous invasion at central venous ligation.

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

Patients undergoing elective curative intended complete mesocolic excision for primary colon adenocarcinoma at Nordsjællands Hospital in Hillerød, Denmark

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34933419	Derived	Gundestrup AK, Olsen ASF, Ingeholm P, Bols B, Kleif J, Bertelsen CA. Nonmicroradical Resection Margin as a Predictor of Recurrence in Patients With Stage III Colon Cancer Undergoing Complete Mesocolic Excision: A Prospective Cohort Study. Dis Colon Rectum. 2022 May 1;65(5):683-691. doi: 10.1097/DCR.0000000000001996.

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