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The Impact of Covid-19 Pandemic on Colorectal Cancer Prevention Due to Delays in Diagnosis: a Global Study (COVID_CRC)

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ClinicalTrials.gov Identifier: NCT04637893
Recruitment Status : Not yet recruiting
First Posted : November 20, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Brief 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.


Condition or disease Intervention/treatment
Colorectal Cancer Other: Colonoscopy

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Impact of Covid-19 Pandemic on Colorectal Cancer Prevention Due to Delays in Diagnosis: a Global Study
Estimated Study Start Date : December 16, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Colonoscopy
    Pt. underwent colonoscopy


Primary Outcome Measures :
  1. Colorectal Cancer prevention [ Time Frame: 3 months ]
    To investigate the impact of COVID-19 pandemic on Colorectal Cancer prevention on a global scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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).
Criteria
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04637893


Contacts
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Contact: Alessandro Repici, MD 0039-02-82247493 alessandro.repici@hunimed.eu
Contact: Roberta Maselli, MD 0039-02.82247570 roberta.maselli@humanitas.it

Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Principal Investigator: Alessandro Repici, MD IRCSS Humanitas Research Hospital
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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT04637893    
Other Study ID Numbers: 100
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases