Colo-rectal CancerDECOR-19NCT04488549
Delayed Colorectal Cancer Care During Coronavirus Disease (COVID-19) Pandemic (DECOR-19)
An observational study of Colo-rectal Cancer and Colon Cancer, run by Treviso Regional Hospital at 1 site in Italy.
Trial summary
To understand and analyse the global impact of COVID-19 on outpatient services, inpatient care, elective surgery, and perioperative colorectal cancer care, a DElayed COloRectal cancer surgery (DECOR-19) survey was conducted in collaboration with numerous international colorectal societies with the objective of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colo-rectal Cancer, Colon Cancer, Rectal Cancer
- What is being tested?
- Survey
- How many people
- 1,051 participants
- Where
- 1 siteItaly
- Study dates
- 20 May 2020to 10 Jun 2020
- 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: The survey link was sent to scientific societies of interest to coloproctologists and disseminated to their members. Participation was entirely voluntary with no compensation offered. Informed consent was obtained from all those agreeing to complete a survey. This study was exempt from review board approval at authors' institutions.
Who may be able to join
- Members of renowned scientific societies with an interest in coloproctology
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DElayed COloRectal Cancer Care During Coronavirus Disease (COVID-19) Pandemic (DECOR-19)
To understand and analyse the global impact of COVID-19 on outpatient services, inpatient care, elective surgery, and perioperative colorectal cancer care, a DElayed COloRectal cancer surgery (DECOR-19) survey was conducted in collaboration with numerous international colorectal societies with the objective of obtaining several learning points from the impact of the COVID-19 outbreak on our colorectal cancer patients which will assist us in the ongoing management of our colorectal cancer patients and to provide us safe oncological pathways for future outbreaks.
- Conditions
- Colo-rectal Cancer, Colon Cancer, Rectal Cancer, Oncology, Surgery
- Being tested
- Survey
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
International E-survey
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive power of respondents' and hospitals' demographics on delaying colorectal cancer care across 6 geographical regions
Respondents' and hospitals' demographics include: gender, country of origin, type of hospital (i.e. academic or not), type of unit (general surgery vs. colorectal), no. hospital beds, no. yearly surgeries for colon and rectal cancer, hospital preparedness to the emergency (i.e. fully or partially dedicated or not involved in COVID-19 care), readily availability of external facilities for colorectal cancer surgery, cancer care coordinator, personal protective equipment, status of elective surgery, no. elective colorectal cancer patients needing urgent surgery, any change in the original management plan, no. colorectal cancer patients refusing surgery or being COVID-19 + on surgery or becoming COVID-19 + post-operatively, no. staff members quarantined or relocated in COVID-19 units, MDT meeting suspension, any delay in endoscopy, radiology, oncology, surgery, histopathology.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start20 May 2020
- Primary completion10 Jun 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,051 participants (actual)
Sponsor and investigators
- Lead sponsor
- Treviso Regional Hospital
- Sponsor type
- Research network
- Collaborators
- Gaetano Gallo, Gian Luca Di Tanna
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488549
- Sponsor's protocol ID
- Treviso
- Acronym
- DECOR-19
- Status last verified
- Jul 2020
- First submitted
- 23 Jul 2020
- Last updated
- 28 Jul 2020
- 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 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DElayed COloRectal Cancer Care During Coronavirus Disease (COVID-19) Pandemic (DECOR-19)
- ClinicalTrials.gov ID
- NCT04488549
- Acronym / sponsor ID
- DECOR-19 / Treviso
- Conditions
- Colo-rectal Cancer, Colon Cancer, Rectal Cancer, Oncology, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,051 participants (actual)
- Lead sponsor
- Treviso Regional HospitalResearch network
- Collaborators
- Gaetano Gallo, Gian Luca Di Tanna
- Study start
- 20 May 2020 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 28 Jul 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.
To understand and analyse the global impact of COVID-19 on outpatient services, inpatient care, elective surgery, and perioperative colorectal cancer care, a DElayed COloRectal cancer surgery (DECOR-19) survey was conducted in collaboration with numerous international colorectal societies with the objective of obtaining several learning points from the impact of the COVID-19 outbreak on our colorectal cancer patients which will assist us in the ongoing management of our colorectal cancer patients and to provide us safe oncological pathways for future outbreaks.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The survey link was sent to scientific societies of interest to coloproctologists and disseminated to their members. Participation was entirely voluntary with no compensation offered. Informed consent was obtained from all those agreeing to complete a survey. This study was exempt from review board approval at authors' institutions.
Key inclusion criteria (1 listed)
- Members of renowned scientific societies with an interest in coloproctology
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 |
|---|---|---|
| SurveyInternational E-survey | Other | – |
Primary outcome
Predictive power of respondents' and hospitals' demographics on delaying colorectal cancer care across 6 geographical regions
Time frame: 20 days
Respondents' and hospitals' demographics include: gender, country of origin, type of hospital (i.e. academic or not), type of unit (general surgery vs. colorectal), no. hospital beds, no. yearly surgeries for colon and rectal cancer, hospital preparedness to the emergency (i.e. fully or partially dedicated or not involved in COVID-19 care), readily availability of external facilities for colorectal cancer surgery, cancer care coordinator, personal protective equipment, status of elective surgery, no. elective colorectal cancer patients needing urgent surgery, any change in the original management plan, no. colorectal cancer patients refusing surgery or being COVID-19 + on surgery or becoming COVID-19 + post-operatively, no. staff members quarantined or relocated in COVID-19 units, MDT meeting suspension, any delay in endoscopy, radiology, oncology, surgery, histopathology.
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 28 Jul 2020.
- 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.
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 Colo-rectal Cancer and Colon Cancer, run by Treviso Regional Hospital at 1 site in Italy.
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 28 Jul 2020. 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 Italy. 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?
Predictive power of respondents' and hospitals' demographics on delaying colorectal cancer care across 6 geographical regions (time frame: 20 days). 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 28 Jul 2020.