NCT03314961

Brief Summary

Lymph node status is of major prognostic importance in non-metastatic rectal cancer. For oncological reasons, central arterial ligation of the inferior mesenteric artery (IMA) is suggested. However, there is no conclusive evidence presented for this procedure. This study aimed at investigating the localisation of lymph node metastases and the role of central versus peripheral arterial ligation of in rectal cancer specimens.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

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

January 1, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

4.9 years

First QC Date

October 16, 2017

Last Update Submit

October 16, 2017

Conditions

Lymph Node Metastases

Keywords

rectal cancer

Outcome Measures

Primary Outcomes (1)

  • Lymph node metastases in rectal cancer

    Analyses of number and location of lymph node metastases in rectal cancer

    2012-2016

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients that were diagnosed with rectal cancer 2012-2016 in Västmanlands county.

You may qualify if:

  • All patients that were curatively operated for rectal cancer in Västmanlands county 2012-2016.

You may not qualify if:

  • Patients that were not operated or had another type of cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphatic MetastasisRectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Catarina Tiselius, MD, PhD

    Region Västmanland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 19, 2017

Study Start

January 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 19, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share