LERIS: Local Recurrence Due to Rectal Cancer in Sweden
Sponsor
Sahlgrenska University Hospital, Sweden (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04404777
Collaborator
(none)
12,000
1
5
2418.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
12000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Local Recurrence Due to Rectal Cancer in Sweden - the Actual Incidence, Treatment and Outcome After Treatment
Anticipated Study Start Date
:
Dec 1, 2021
Anticipated Primary Completion Date
:
Dec 1, 2021
Anticipated Study Completion Date
:
May 1, 2022
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Number of local recurrences [Between 2007-2018]
- 3 year survival [3 years]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
- Rectal cancer with a curative intent
Exclusion Criteria:
- Rectal cancer without curative intent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dept. of Surgery, Sahlgrenska University Hospital/Ostra | Gothenburg | Sweden | SE 416 85 |
Sponsors and Collaborators
- Sahlgrenska University Hospital, Sweden
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eva Angenete,
PI,
Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT04404777
Other Study ID Numbers:
- LERIS
First Posted:
May 28, 2020
Last Update Posted:
Jul 16, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: