Rectal CancerCovidRCNCT05328960
The Pandemic's Effect on Diagnosis and Treatment of Rectal Cancer
An observational study of Rectal Cancer, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Colorectal cancer is common with an annual prevalence of 6000. The majority can be cured and the five year survival rate is over 60%. In december 2019 reports came in about SARS-Cov-2, which later was named Covid-19. The World Health Organization classified it as a pandemic in March 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Diagnosed during or not during the pandemic
- How many people
- 8,000 participants
- Where
- 1 siteSweden
- Study dates
- 15 Feb 2022to 31 Dec 2025
- 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 that are diagnosed with rectal cancer and identified in the Swedish ColoRectal Cancer Registry will be included. They will be contacted by phone and mail regarding a questionnaire.
Who may be able to join
- Rectal cancer diagnosis 2019-2022
Who cannot join
- No rectal cancer diagnosis 2019-2022
Trial locations and contacts
1 site in 1 country.
Anette Wedin, RN contact
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
Anette Wedin, RN
About this study
Official title: An Analysis of Covid-19 Effect on Patients With Colorectal Cancer - Follow-up Regarding Tumour Stage, Neoadjuvant Treatment, Delay and Long-term Survival
Colorectal cancer is common with an annual prevalence of 6000. The majority can be cured and the five year survival rate is over 60%. In december 2019 reports came in about SARS-Cov-2, which later was named Covid-19. The World Health Organization classified it as a pandemic in March 2020. In Sweden the number of patients with Covid-19 increased mainly in the urban areas in March 2020. Care for patients with other diseases were affected and local changes from guidelines were adopted. In some regions and countries the indications for adjuvant and neoadjuvant treatment for colorectal cancer were somewhat changed. The number of patients diagnosed with colorectal cancer also decreased, as well as other types of cancer. The true effect on outcome with a delayed diagnosis remains unknown.
The aim of this study is to evaluate the effects of the Covid-19 pandemic on the diagnosis, treatment and survival of patients with colorectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- Diagnosed during or not during the pandemic
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosed during or not during the pandemicOther
We will create a group of patients that are diagnosed before and after the pandemic and one group diagnosed during the pandemic
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed before, during or after the pandemic | Patients with rectal cancer Receives: Other: Diagnosed during or not during the pandemic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yearly incidence of rectal cancer
The number of patients diagnosed yearly 2019, 2020, 2021 and 2022
Measured: 2019-2022
Secondary outcomes (4)
Symptoms at diagnosis
Symptoms at diagnosis as reported by patients
Measured: 6 months prior diagnosis
Patient's delay
Delay from symptoms until doctors appointment
Measured: 12 months prior diagnosis
Doctor's delay
Delay from doctor's appointment until diagnosis
Measured: 12 months prior diagnosis
Treatment changes
Any changes from the treatment plan due to covid-19
Measured: Diagnosis and 12 months following
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start15 Feb 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- Retrospective
- Enrolment
- 8,000 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
- NCT05328960
- Sponsor's protocol ID
- CovidRC
- Acronym
- CovidRC
- Status last verified
- Dec 2023
- First submitted
- 13 Apr 2022
- 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
- An Analysis of Covid-19 Effect on Patients With Colorectal Cancer - Follow-up Regarding Tumour Stage, Neoadjuvant Treatment, Delay and Long-term Survival
- ClinicalTrials.gov ID
- NCT05328960
- Acronym / sponsor ID
- CovidRC / CovidRC
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Apr 2022 (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.
Colorectal cancer is common with an annual prevalence of 6000. The majority can be cured and the five year survival rate is over 60%. In december 2019 reports came in about SARS-Cov-2, which later was named Covid-19. The World Health Organization classified it as a pandemic in March 2020. In Sweden the number of patients with Covid-19 increased mainly in the urban areas in March 2020. Care for patients with other diseases were affected and local changes from guidelines were adopted. In some regions and countries the indications for adjuvant and neoadjuvant treatment for colorectal cancer were somewhat changed. The number of patients diagnosed with colorectal cancer also decreased, as well as other types of cancer. The true effect on outcome with a delayed diagnosis remains unknown.
The aim of this study is to evaluate the effects of the Covid-19 pandemic on the diagnosis, treatment and survival of patients with colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed before, during or after the pandemic | – | Other: Diagnosed during or not during the pandemicPatients with rectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that are diagnosed with rectal cancer and identified in the Swedish ColoRectal Cancer Registry will be included. They will be contacted by phone and mail regarding a questionnaire.
Key inclusion criteria (1 listed)
- Rectal cancer diagnosis 2019-2022
Key exclusion criteria (1 listed)
- No rectal cancer diagnosis 2019-2022
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 |
|---|---|---|
| Diagnosed during or not during the pandemicWe will create a group of patients that are diagnosed before and after the pandemic and one group diagnosed during the pandemic | Other | Patients diagnosed before, during or after the pandemic |
Primary outcome
Yearly incidence of rectal cancer
Time frame: 2019-2022
The number of patients diagnosed yearly 2019, 2020, 2021 and 2022
4 secondary outcomes
Symptoms at diagnosis
Time frame: 6 months prior diagnosis
Patient's delay
Time frame: 12 months prior diagnosis
Doctor's delay
Time frame: 12 months prior diagnosis
Treatment changes
Time frame: Diagnosis and 12 months following
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.
Anette Wedin, RN contact
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 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: 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?
Yearly incidence of rectal cancer (time frame: 2019-2022). 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.