Rectal NeoplasmsLERISNCT04404777
Local Recurrence Due to Rectal Cancer in Sweden
An observational study of Rectal Neoplasms, run by Sahlgrenska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Treatment for local recurrence with surgery or other treatments
- Type of treatment
- Surgery or procedure
- How many people
- 12,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jul 2022to 1 Jun 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Rectal cancer with a curative intent
Who cannot join
- Rectal cancer without curative intent
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Gothenburg, SE 416 85
About this study
Official title: 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.
- Conditions
- Rectal Neoplasms
- Being tested
- Treatment for local recurrence with surgery or other treatments
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment for local recurrence with surgery or other treatmentsProcedure or surgery
All types of treatment for local recurrence will be evaluated
| Study group | Role | What they receive |
|---|---|---|
| Patients with local recurrence | Not described Receives: Procedure: Treatment for local recurrence with surgery or other treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of local recurrences
Measured: Between 2007-2018
3 year survival
Measured: 3 years
Secondary outcomes (4)
Percentage R0 resection after local recurrence
Measured: 1-2 months after initiated treatment
MDT effect on treatment of local recurrence
Measured: 1-3 months after diagnosis of recurrence
Reported metastases
Number of patients with metastasis reported vs actual
Measured: 5 years
MRI features at primary diagnosis and relation to recurrence
MRI evaluation by radiologist related to recurrence
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Jul 2022
- Primary completion1 Aug 2023
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 12,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Angenete, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404777
- Sponsor's protocol ID
- LERIS
- Acronym
- LERIS
- Status last verified
- Jun 2025
- First submitted
- 24 May 2020
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Recurrence Due to Rectal Cancer in Sweden - the Actual Incidence, Treatment and Outcome After Treatment
- ClinicalTrials.gov ID
- NCT04404777
- Acronym / sponsor ID
- LERIS / LERIS
- Conditions
- Rectal Neoplasms
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with local recurrence | – | Procedure: Treatment for local recurrence with surgery or other treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Rectal cancer with a curative intent
Key exclusion criteria (1 listed)
- Rectal cancer without curative intent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment for local recurrence with surgery or other treatmentsAll types of treatment for local recurrence will be evaluated | Procedure or surgery | Patients with local recurrence |
Primary outcome
Number of local recurrences
Time frame: Between 2007-2018
3 year survival
Time frame: 3 years
4 secondary outcomes
Percentage R0 resection after local recurrence
Time frame: 1-2 months after initiated treatment
MDT effect on treatment of local recurrence
Time frame: 1-3 months after diagnosis of recurrence
Reported metastases
Time frame: 5 years
MRI features at primary diagnosis and relation to recurrence
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Rectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Neoplasms, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of local recurrences (time frame: Between 2007-2018). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.