Local Recurrence Due to Rectal Cancer in Sweden

NCT04404777 | Active Not Recruiting

• 1 other identifier: LERIS
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (2)

• Number of local recurrences

  Between 2007-2018

• 3 year survival

  3 years

Secondary Outcomes (4)

• Percentage R0 resection after local recurrence

  1-2 months after initiated treatment

• MDT effect on treatment of local recurrence

  1-3 months after diagnosis of recurrence

• Reported metastases

  5 years

• MRI features at primary diagnosis and relation to recurrence

  2 months

Study Arms (1)

Patients with local recurrence

Procedure: Treatment for local recurrence with surgery or other treatments

Interventions

Treatment for local recurrence with surgery or other treatments PROCEDURE

All types of treatment for local recurrence will be evaluated

Patients with local recurrence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Rectal cancer with a curative intent

You may not qualify if:

• Rectal cancer without curative intent

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Therapeutics; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 24, 2020
• First Posted: May 28, 2020
• Study Start: July 1, 2022
• Primary Completion: August 1, 2023
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

SE (1)