Rectal NeoplasmsTRECANCT04788368
TRECA - TREatment of Colorectal Adenomas and Early Colorectal CAncer in Region Västra Götaland
An observational study of Rectal Neoplasms, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
All early colorectal cancers (T1-T2) treated in the Region Västra Götaland from 2007-2020 will be evaluated. To establish the extent to which early colorectal cancers have been treated with local excision? How have treatment strategies changed over time? The study will provide information on where these patients have… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Surgical resection
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2021to 31 Dec 2021
- How long will I take part?
- 2 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with rectal cancer treated with a local resection
Who may be able to join
- Rectal cancer resected by local resection
Who cannot join
- All other types of resection or treatment for rectal cancer
Trial locations and contacts
1 site in 1 country.
About this study
All early colorectal cancers (T1-T2) treated in the Region Västra Götaland from 2007-2020 will be evaluated. To establish the extent to which early colorectal cancers have been treated with local excision? How have treatment strategies changed over time? The study will provide information on where these patients have been treated in the Region Västra Götaland. During the study period, ESD was introduced as a treatment modality, and it will investigated how this may have influenced treatment strategies for complex adenomas. Clinical outcome measures will include recurrence rates and re-intervention rates for the respective treatments. Possible areas of improvement will be identified and determine if evidence based and best practice guidelines are met with the current treatment strategies in Region Västra Götaland.
- Conditions
- Rectal Neoplasms
- Being tested
- Surgical resection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical resectionProcedure or surgery
Surgical resection with either of the above mentioned techniques
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with TEM - transanala microsurgery | Early rectal cancer treated with TEM - full thickness resection Receives: Procedure: Surgical resection | |
| Patients treated with ESD | Early rectal cancer treated with the endoscopic treatment ESD - endoscopic submucosal resection Receives: Procedure: Surgical resection | |
| Patients treated with EMR | Early rectal cancer treated with the endoscopic treatment EMR - endoscopic mucosal resection Receives: Procedure: Surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological clear margins
Pathological examination of the specimen showing free margins
Measured: 1-2 months after surgery
Complications after surgery
Complications graded using the Clavien Dindo classification
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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
- Case only
- Time perspective
- Other
- Enrolment
- 300 participants (actual)
- Target duration
- 2 Months
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
- NCT04788368
- Sponsor's protocol ID
- TRECA
- Acronym
- TRECA
- Status last verified
- Nov 2022
- First submitted
- 5 Mar 2021
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRECA - TREatment of Colorectal Adenomas and Early Colorectal CAncer in Region Västra Götaland
- ClinicalTrials.gov ID
- NCT04788368
- Acronym / sponsor ID
- TRECA / TRECA
- Conditions
- Rectal Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Mar 2021 (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.
All early colorectal cancers (T1-T2) treated in the Region Västra Götaland from 2007-2020 will be evaluated. To establish the extent to which early colorectal cancers have been treated with local excision? How have treatment strategies changed over time? The study will provide information on where these patients have been treated in the Region Västra Götaland. During the study period, ESD was introduced as a treatment modality, and it will investigated how this may have influenced treatment strategies for complex adenomas. Clinical outcome measures will include recurrence rates and re-intervention rates for the respective treatments. Possible areas of improvement will be identified and determine if evidence based and best practice guidelines are met with the current treatment strategies in Region Västra Götaland.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 2 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients treated with TEM - transanala microsurgery | – | Procedure: Surgical resectionEarly rectal cancer treated with TEM - full thickness resection |
| Patients treated with ESD | – | Procedure: Surgical resectionEarly rectal cancer treated with the endoscopic treatment ESD - endoscopic submucosal resection |
| Patients treated with EMR | – | Procedure: Surgical resectionEarly rectal cancer treated with the endoscopic treatment EMR - endoscopic mucosal resection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with rectal cancer treated with a local resection
Key inclusion criteria (1 listed)
- Rectal cancer resected by local resection
Key exclusion criteria (1 listed)
- All other types of resection or treatment for rectal cancer
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 |
|---|---|---|
| Surgical resectionSurgical resection with either of the above mentioned techniques | Procedure or surgery | Patients treated with EMR, Patients treated with ESD, Patients treated with TEM - transanala microsurgery |
Primary outcome
Pathological clear margins
Time frame: 1-2 months after surgery
Pathological examination of the specimen showing free margins
Complications after surgery
Time frame: 90 days after surgery
Complications graded using the Clavien Dindo classification
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: No
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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.
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: finished, as of the sponsor's last update on 7 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pathological clear margins (time frame: 1-2 months after surgery). 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 7 Nov 2022.