Colorectal CancerTidopNCT04571047
Time to Surgery - the Impact of Waiting Time on Outcome After Colorectal Cancer Treatment
An observational study of Colorectal Cancer, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
We aim to perform a register-based, observational cohort study to investigate whether it is safe to delay start of treatment with a curative intention after a colorectal cancer diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Time to treatment
- How many people
- 40,000 participants
- Where
- 1 siteSweden
- Study dates
- 15 Oct 2020to 15 Sep 2021
- How long will I take part?
- 3 Years
- 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 registered with a diagnosis of colorectal cancer in Sweden between 2008-2016
Who may be able to join
- Diagnosed with colorectal cancer 2008-2016 in Sweden
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
We aim to perform a register-based, observational cohort study to investigate whether it is safe to delay start of treatment with a curative intention after a colorectal cancer diagnosis. Our hypothesis is that delaying start of treatment until 4-8 weeks is as safe as starting treatment within four weeks after a colorectal cancer diagnosis.
- Conditions
- Colorectal Cancer
- Being tested
- Time to treatment
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time to treatmentOther
Treatment before or after 4 weeks after diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer patients | Patients diagnosed with colonrectal cancer between 2008-2016 Receives: Other: Time to treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival
Measured: 3 years
Secondary outcomes (4)
Length of stay
Hospital stay
Measured: 90 days
Re-operations within 3 months
Surgical procedures registered within 3 months after the procedure date
Measured: 90 days
Re-admissions within 3 months
Readmissions registered within 3 months after the procedure date
Measured: 90 days
Radical surgery
Defined as R0 resection
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start15 Oct 2020
- Primary completion15 Jul 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Prospective
- Enrolment
- 40,000 participants (actual)
- 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
- Investigators
- Eva Angenete, Principal investigator, Sahlgrenska Universitetssjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571047
- Sponsor's protocol ID
- Tidop
- Acronym
- Tidop
- Status last verified
- Dec 2021
- First submitted
- 2 Sep 2020
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data is extracted from CRCBaSe, (ColoRectal Cancer Data Base) a combination of several registries in Sweden and thus the sharing option will be decided by that work group
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Surgery - the Impact of Waiting Time on Outcome After Colorectal Cancer Treatment
- ClinicalTrials.gov ID
- NCT04571047
- Acronym / sponsor ID
- Tidop / Tidop
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40,000 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 30 Sep 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.
We aim to perform a register-based, observational cohort study to investigate whether it is safe to delay start of treatment with a curative intention after a colorectal cancer diagnosis. Our hypothesis is that delaying start of treatment until 4-8 weeks is as safe as starting treatment within four weeks after a colorectal cancer diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer patients | – | Other: Time to treatmentPatients diagnosed with colonrectal cancer between 2008-2016 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients registered with a diagnosis of colorectal cancer in Sweden between 2008-2016
Key inclusion criteria (1 listed)
- Diagnosed with colorectal cancer 2008-2016 in Sweden
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Time to treatmentTreatment before or after 4 weeks after diagnosis | Other | Colorectal cancer patients |
Primary outcome
Overall survival
Time frame: 3 years
Overall survival
4 secondary outcomes
Length of stay
Time frame: 90 days
Re-operations within 3 months
Time frame: 90 days
Re-admissions within 3 months
Time frame: 90 days
Radical surgery
Time frame: 90 days
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 2 Dec 2021.
- Individual participant dataSharing planned: Undecided. The data is extracted from CRCBaSe, (ColoRectal Cancer Data Base) a combination of several registries in Sweden and thus the sharing option will be decided by that work group
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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.
Eva Angenete principal investigator
Sahlgrenska Universitetssjukhuset
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 Cancer, 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 2 Dec 2021. 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?
Overall survival (time frame: 3 years). 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 2 Dec 2021.