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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04637893
Other study ID # 100
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 16, 2020
Est. completion date March 31, 2021

Study information

Verified date June 2022
Source Istituto Clinico Humanitas
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date March 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility - 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Colonoscopy
Pt. underwent colonoscopy

Locations

Country Name City State
Italy Endoscopy Unit, Humanitas Research Hospital Rozzano Milano

Sponsors (1)

Lead Sponsor Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Colorectal Cancer prevention To investigate the impact of COVID-19 pandemic on Colorectal Cancer prevention on a global scale. 3 months
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