NCT04395534

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
276

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Status
completed

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

June 1, 2008

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

11.8 years

First QC Date

May 15, 2020

Last Update Submit

May 15, 2020

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    Any type of recurrence

    3 years

Interventions

Complete mesocolic excisionPROCEDURE

Eligibility Criteria

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

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34933419DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant Colorectal Surgeon, Associate Professor, Head of Research Department of Surgery

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 20, 2020

Study Start

June 1, 2008

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

May 20, 2020

Record last verified: 2020-05