Local Recurrence Due to Rectal Cancer in Sweden (LERIS)

June 12, 2025 updated by: Eva Angenete, Sahlgrenska University Hospital

Local Recurrence Due to Rectal Cancer in Sweden - the Actual Incidence, Treatment and Outcome After Treatment

The aim of this retrospective national registry study is to validate the reporting of local recurrence in the registry. Another aim is to identify preoperative risk factors for local recurrence. This can in turn indicate the need for a more intense follow-up. The treatment of local recurrence, including the impact of the multidisciplinary team conference (MDT) and the surgical procedure and the referral pathways of local recurrences will also be determined.

We aim to evaluate treatment outcome after local recurrence for patients operated or treated between 2007-2018.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

12000

Contacts and Locations

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

Study Locations

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

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

N/A

Sampling Method

Probability Sample

Study Population

All patients treated in Sweden with a curative intent in 2007-2018 will be included. The number of recurrences, patterns of recurrence and outcome after treatment will be evaluated

Description

Inclusion Criteria:

  • Rectal cancer with a curative intent

Exclusion Criteria:

  • Rectal cancer without curative intent

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: Treatment for local recurrence with surgery or other treatments
All types of treatment for local recurrence will be evaluated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of local recurrences
Time Frame: Between 2007-2018
Between 2007-2018
3 year survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage R0 resection after local recurrence
Time Frame: 1-2 months after initiated treatment
1-2 months after initiated treatment
MDT effect on treatment of local recurrence
Time Frame: 1-3 months after diagnosis of recurrence
1-3 months after diagnosis of recurrence
Reported metastases
Time Frame: 5 years
Number of patients with metastasis reported vs actual
5 years
MRI features at primary diagnosis and relation to recurrence
Time Frame: 2 months
MRI evaluation by radiologist related to recurrence
2 months

Collaborators and Investigators

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

Sponsor

Sahlgrenska University Hospital

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)

July 1, 2022

Primary Completion (Actual)

August 1, 2023

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

May 24, 2020

First Submitted That Met QC Criteria

May 24, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

June 17, 2025

Last Update Submitted That Met QC Criteria

June 12, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LERIS

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

product manufactured in and exported from the U.S.

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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