Colorectal NeoplasmsNCT04406974
Locally Advanced Colorectal Cancer and Local Recurrences in Västra Götaland
An observational study of Colorectal Neoplasms, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The aim of this study is to review the treatment strategies of locally advanced colorectal cancer and locally recurrent rectal cancer in Västra Götaland during 1995-2016. The aim is to evaluate time trends and outcome both related to morbidity and cancer specific survival, we will also evaluate the results after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Surgery or treatment for local recurrence and Surgery for advanced colorectal cancer
- Type of treatment
- Surgery or procedure
- How many people
- 4,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2018to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated in Region Västra Götaland 1995-2018 for colorectal cancer will be identified using the local Swedish Colorectal Cancer Registry. Further selection will depend on the primary outcome in substudies.
Who may be able to join
- Locally advanced rectal cancer
- Local recurrence for colorectal cancer
- Curative treatment for colorectal cancer
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Gothenburg, SE 416 85
Eva Angenete, MD,PhD, +46313438410, eva.angenete@vgregion.se
About this study
Official title: Locally Advanced Colorectal Cancer and Recurrence After Colorectal Cancer in Region Västra Götaland
The aim of this study is to review the treatment strategies of locally advanced colorectal cancer and locally recurrent rectal cancer in Västra Götaland during 1995-2016. The aim is to evaluate time trends and outcome both related to morbidity and cancer specific survival, we will also evaluate the results after advanced reconstruction. The study will identify the population using the Swedish ColoRectal Cancer Registry and then the individual patient charts will be reviewed. The data will be collected in a clinical record form covering demography (age, sex, co-morbidity, BMI and diagnoses) as well as treatments strategy, surgical procedures, re-operations, complications, readmissions, hospital stay, stoma formation etc.
- Conditions
- Colorectal Neoplasms
- Being tested
- Surgery or treatment for local recurrence, Surgery for advanced colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery or treatment for local recurrenceProcedure or surgery
Surgery or treatment for local recurrence
Surgery for advanced colorectal cancerProcedure or surgery
Surgery for advanced colorectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Patients with local recurrence | Not described Receives: Procedure: Surgery or treatment for local recurrence; Procedure: Surgery for advanced colorectal cancer | |
| Patients with advanced colorectal cancer | Not described Receives: Procedure: Surgery or treatment for local recurrence; Procedure: Surgery for advanced colorectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival after local recurrence
Measured: 3 years
Risk factors for local recurrence
Measured: Preoperative data, about 1 month prior surgery
Complications after urinary reconstruction surgery for locally advanced cancer
Measured: 90 days
Patient experiences after local recurrence
Indepth interviews with patients with local recurrence
Measured: 3 years postopeartively after local recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Jan 2018
- Primary completion1 Dec 2022
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Retrospective
- Enrolment
- 4,000 participants (estimated)
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
- NCT04406974
- Sponsor's protocol ID
- Lokalrecidiv i VGR
- Status last verified
- Dec 2023
- First submitted
- 24 May 2020
- Last updated
- 8 Dec 2023
- 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 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locally Advanced Colorectal Cancer and Recurrence After Colorectal Cancer in Region Västra Götaland
- ClinicalTrials.gov ID
- NCT04406974
- Acronym / sponsor ID
- Lokalrecidiv i VGR
- Conditions
- Colorectal Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 29 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 study is to review the treatment strategies of locally advanced colorectal cancer and locally recurrent rectal cancer in Västra Götaland during 1995-2016. The aim is to evaluate time trends and outcome both related to morbidity and cancer specific survival, we will also evaluate the results after advanced reconstruction. The study will identify the population using the Swedish ColoRectal Cancer Registry and then the individual patient charts will be reviewed. The data will be collected in a clinical record form covering demography (age, sex, co-morbidity, BMI and diagnoses) as well as treatments strategy, surgical procedures, re-operations, complications, readmissions, hospital stay, stoma formation etc.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with local recurrence | – | Procedure: Surgery or treatment for local recurrence, Procedure: Surgery for advanced colorectal cancer |
| Patients with advanced colorectal cancer | – | Procedure: Surgery or treatment for local recurrence, Procedure: Surgery for advanced colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated in Region Västra Götaland 1995-2018 for colorectal cancer will be identified using the local Swedish Colorectal Cancer Registry. Further selection will depend on the primary outcome in substudies.
Key inclusion criteria (3 listed)
- Locally advanced rectal cancer
- Local recurrence for colorectal cancer
- Curative treatment for colorectal cancer
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Surgery or treatment for local recurrenceSurgery or treatment for local recurrence | Procedure or surgery | Patients with advanced colorectal cancer, Patients with local recurrence |
| Surgery for advanced colorectal cancerSurgery for advanced colorectal cancer | Procedure or surgery | Patients with advanced colorectal cancer, Patients with local recurrence |
Primary outcome
Survival after local recurrence
Time frame: 3 years
Risk factors for local recurrence
Time frame: Preoperative data, about 1 month prior surgery
Complications after urinary reconstruction surgery for locally advanced cancer
Time frame: 90 days
Patient experiences after local recurrence
Time frame: 3 years postopeartively after local recurrence
Indepth interviews with patients with local recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Colorectal 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 3 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: status not confirmed, as of the sponsor's last update on 8 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Angenete, MD. PhD (0760514441, eva.angenete@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival after local recurrence (time frame: 3 years). The study lists 4 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 8 Dec 2023.