Locally Advanced Colorectal Cancer and Local Recurrences in Västra Götaland

December 7, 2023 updated by: Eva Angenete, Sahlgrenska University Hospital, Sweden

Locally Advanced Colorectal Cancer and Recurrence After Colorectal Cancer in Region Västra Götaland

The aim of this study is to review the treatment strategies of locally advanced colorectal cancer and locally recurrent rectal cancer in Västra Götaland during 1995-2016. The aim is to evaluate time trends and outcome both related to morbidity and cancer specific survival, we will also evaluate the results after advanced reconstruction. The study will identify the population using the Swedish ColoRectal Cancer Registry and then the individual patient charts will be reviewed. The data will be collected in a clinical record form covering demography (age, sex, co-morbidity, BMI and diagnoses) as well as treatments strategy, surgical procedures, re-operations, complications, readmissions, hospital stay, stoma formation etc.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Gothenburg, Sweden, SE 416 85
        • Recruiting
        • Dept. of Surgery, Sahlgrenska University Hospital/Ostra
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients treated in Region Västra Götaland 1995-2018 for colorectal cancer will be identified using the local Swedish Colorectal Cancer Registry. Further selection will depend on the primary outcome in substudies.

Description

Inclusion Criteria:

  • Locally advanced rectal cancer
  • Local recurrence for colorectal cancer
  • Curative treatment for colorectal cancer

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with local recurrence
Procedure: Surgery or treatment for local recurrence
Surgery or treatment for local recurrence
Procedure: Surgery for advanced colorectal cancer
Surgery for advanced colorectal cancer
Patients with advanced colorectal cancer
Procedure: Surgery or treatment for local recurrence
Surgery or treatment for local recurrence
Procedure: Surgery for advanced colorectal cancer
Surgery for advanced colorectal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival after local recurrence
Time Frame: 3 years
3 years
Risk factors for local recurrence
Time Frame: Preoperative data, about 1 month prior surgery
Preoperative data, about 1 month prior surgery
Complications after urinary reconstruction surgery for locally advanced cancer
Time Frame: 90 days
90 days
Patient experiences after local recurrence
Time Frame: 3 years postopeartively after local recurrence
Indepth interviews with patients with local recurrence
3 years postopeartively after local recurrence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 1, 2022

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 24, 2020

First Submitted That Met QC Criteria

May 24, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lokalrecidiv i VGR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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