Colorectal CancerCOVID_CRCNCT04637893
The Impact of Covid-19 Pandemic on Colorectal Cancer Prevention Due to Delays in Diagnosis: a Global Study
An observational study of Colorectal Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Screening programs have been associated with a substantial reduction in colorectal cancer (CRC) mortality through endoscopic resection of preneoplastic lesions and detection of early-stage invasive cancers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Colonoscopy
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 16 Dec 2020to 31 Mar 2021
- 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: All patients who underwent colonoscopy between the 1st October 2020 and the 31st December 2020 (pandemic cohort), and all patients who underwent colonoscopy between the 1st October 2019 and the 31st December 2019 (pre-pandemic cohort).
- patients who underwent colonoscopy between the 1st October 2020 and the 31st December 2020 (pandemic cohort)
- patients who underwent colonoscopy between the 1st October 2019 and the 31st December 2019 (pre-pandemic cohort)
Trial locations and contacts
1 site in 1 country.
About this study
Screening programs have been associated with a substantial reduction in colorectal cancer (CRC) mortality through endoscopic resection of preneoplastic lesions and detection of early-stage invasive cancers.
In March 2020, the World Health Organization declared as a pandemic the outbreak of coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2. Since then, the SARS-CoV-2 have never stopped spreading, causing an unprecedented situation with highly restrictive considerations to be adopted by the majority of countries worldwide.
Health-care facilities have been making an enormous effort to assist patients affected by COVID-19, while adopting measures to maintain a safe environment for patients and healthcare professionals. As a result, the usual workflow in endoscopy departments changed dramatically, leading to an increase in cancelled procedures, probably increasing the future burden of Colorectal Cancer due to delays in diagnosis.
- Conditions
- Colorectal Cancer
- Being tested
- Colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyOther
Pt. underwent colonoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal Cancer prevention
To investigate the impact of COVID-19 pandemic on Colorectal Cancer prevention on a global scale.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start16 Dec 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 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 Istituto Clinico HumanitasThe 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro Repici, MD, Principal investigator, IRCSS Humanitas Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637893
- Sponsor's protocol ID
- 100
- Acronym
- COVID_CRC
- Status last verified
- Jun 2022
- First submitted
- 18 Nov 2020
- Last updated
- 8 Jun 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 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Covid-19 Pandemic on Colorectal Cancer Prevention Due to Delays in Diagnosis: a Global Study
- ClinicalTrials.gov ID
- NCT04637893
- Acronym / sponsor ID
- COVID_CRC / 100
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 20 Nov 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.
Screening programs have been associated with a substantial reduction in colorectal cancer (CRC) mortality through endoscopic resection of preneoplastic lesions and detection of early-stage invasive cancers.
In March 2020, the World Health Organization declared as a pandemic the outbreak of coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2. Since then, the SARS-CoV-2 have never stopped spreading, causing an unprecedented situation with highly restrictive considerations to be adopted by the majority of countries worldwide.
Health-care facilities have been making an enormous effort to assist patients affected by COVID-19, while adopting measures to maintain a safe environment for patients and healthcare professionals. As a result, the usual workflow in endoscopy departments changed dramatically, leading to an increase in cancelled procedures, probably increasing the future burden of Colorectal Cancer due to delays in diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent colonoscopy between the 1st October 2020 and the 31st December 2020 (pandemic cohort), and all patients who underwent colonoscopy between the 1st October 2019 and the 31st December 2019 (pre-pandemic cohort).
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 |
|---|---|---|
| ColonoscopyPt. underwent colonoscopy | Other | – |
Primary outcome
Colorectal Cancer prevention
Time frame: 3 months
To investigate the impact of COVID-19 pandemic on Colorectal Cancer prevention on a global scale.
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 8 Jun 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.
Alessandro Repici, MD principal investigator
IRCSS Humanitas Research Hospital
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 Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 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 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?
Colorectal Cancer prevention (time frame: 3 months). 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 Jun 2022.