- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07328399
Impact of COVID-19 Pandemic Waves on Colorectal Cancer Stage Migration and Diagnostic Delays
January 3, 2026 updated by: University of Pecs
Background/Objectives: The incidence of colorectal cancer in Hungary exceeds the EU (European Union) average, and the cancer mortality rate is also among the highest in the country.
The COVID-19 pandemic has impacted various areas of healthcare, including cancer diagnosis and treatment.
Due to the measures taken to combat the COVID-19 pandemic, not only newly suspected cancer patients but also those already diagnosed and undergoing treatment faced numerous difficulties.
Methods: The study included 198 patients with colorectal cancer, of whom 43 participants were newly diagnosed cases.
Due to low case numbers in certain COVID-19 waves, adjacent waves were merged for statistical analysis.
The number of newly diagnosed colorectal cancer cases across COVID-19 waves was compared using one-way ANOVA, stage distribution differences and the proportion of missed treatments were assessed with Fisher's exact test.
In follow-up patients, changes were analyzed using the Wilcoxon signed-rank test.
Differences in tumor size categories were examined using chi-square tests.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
198
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Budapest, Hungary, 1032
- Szent Margit Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients with colorectal cancer undergoing MRI examination during and after the COVID-19 pandemic.
Description
Inclusion Criteria:
- Patients with suspected or confirmed colorectal cancer
- Patients examined by MRI at Szent Margit Hospital
- MRI referral issued between September 2020 and December 2023
Exclusion Criteria:
- MRI referrals not issued by Szent Margit Hospital
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Colorectal cancer patients
Patients with colorectal cancer undergoing MRI examination during and after the COVID-19 pandemic.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Tumor stage distribution across COVID-19 pandemic waves
Time Frame: September 2020 - December 2023
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Comparison of colorectal cancer tumor stage (AJCC 8th edition) across different COVID-19 pandemic waves and the post-COVID period based on MRI findings.
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September 2020 - December 2023
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Number of newly diagnosed colorectal cancer cases
Time Frame: September 2020 - December 2023
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Monthly number of newly diagnosed colorectal cancer cases across COVID-19 waves and the post-COVID period.
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September 2020 - December 2023
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TNM classification
Time Frame: September 2020 - December 2023
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TNM classification of colorectal cancer according to the AJCC 8th edition during different COVID-19 pandemic waves in newly diagnosed and follow-up patients.
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September 2020 - December 2023
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Tumor progression or regression in follow-up patients
Time Frame: September 2020 - December 2023
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Change in tumor stage between previous imaging and most recent MRI examination.
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September 2020 - December 2023
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Missed oncologic treatments
Time Frame: September 2020 - December 2023
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Occurrence of missed or delayed oncologic treatments documented during the COVID-19 pandemic period.
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September 2020 - December 2023
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Presence and distribution of metastases
Time Frame: September 2020 - December 2023
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Presence, number, and organ distribution of metastatic disease based on imaging findings.
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September 2020 - December 2023
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: József Tollár, Dr., University of Pécs, Faculty of Health Sciences, Hungary
- Principal Investigator: Adrienn Biró, Dr., Somogy County Móricz Kaposi Teaching Hospital, 7400 Kaposvár, Hungary
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
December 14, 2025
First Submitted That Met QC Criteria
January 3, 2026
First Posted (Actual)
January 9, 2026
Study Record Updates
Last Update Posted (Actual)
January 9, 2026
Last Update Submitted That Met QC Criteria
January 3, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Lung Diseases
- Colonic Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- COVID-19
- Colorectal Neoplasms
Other Study ID Numbers
- IG/2037-1/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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