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NCT04404777 Clinical Trial

Local Recurrence Due to Rectal Cancer in Sweden

Rectal Neoplasms Clinical Trial

— LERIS  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04404777
Other study ID # LERIS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date August 1, 2025

Study information
Verified date November 2023
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 12000
Est. completion date August 1, 2025
Est. primary completion date August 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Rectal cancer with a curative intent Exclusion Criteria: - Rectal cancer without curative intent

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Sweden Dept. of Surgery, Sahlgrenska University Hospital/Ostra Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of local recurrences Between 2007-2018
Primary 3 year survival 3 years
Secondary Percentage R0 resection after local recurrence 1-2 months after initiated treatment
Secondary MDT effect on treatment of local recurrence 1-3 months after diagnosis of recurrence
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