- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04797624
Does Coronavirus Disease 2019 (COVID-19) Pandemic Cause a Delay in the Diagnosis of Gastric Cancer Patients?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study included the patients diagnosed with gastric cancer during the period between March 1, 2020, and December 31, 2020, in the pandemic group at the Adana City Training and Research Hospital, Department of General Surgery, Divisions of Gastroenterological Surgery and Surgical Oncology. For the baseline group, patients diagnosed with gastric cancer between January 1, 2019, and December 31, 2019, was included in the same department.
Clinical and pathological data of the patients were retrospectively collected from the hospital medical records. The following parameters were compared between the pandemic and baseline periods; age and gender distributions, mean monthly numbers of newly diagnosed patients, CEA and CEA-19.9 levels, the type of the surgery, the location of the tumor, the frequency of the patients receiving neoadjuvant treatment, American Society of Anesthesiologists (ASA) score, length of the hospital stay, clinical staging and pathologic TNM staging.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Yuregir
-
Adana, Yuregir, Turkey, 01370
- Adana City Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients newly diagnosed with gastric cancer at specified intervals will be included in the study.
Exclusion Criteria:
- Having an additional second primary tumor
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Baseline group
The baseline group included the patients diagnosed with gastric cancer between January 1, 2019, and December 31, 2019, in the pandemic group at the Adana City Training and Research Hospital, Department of General Surgery, Divisions of Gastroenterological Surgery and Surgical Oncology.
Gastric cancer surgery for adequate patients.
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Appropriate gastric cancer surgery types for the convenient patients
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Pandemic group
The pandemic group included the patients diagnosed with gastric cancer during the period between March 1, 2020, and December 31, 2020, in the pandemic group at the Adana City Training and Research Hospital, Department of General Surgery, Divisions of Gastroenterological Surgery and Surgical Oncology.
Gastric cancer surgery for adequate patients.
|
Appropriate gastric cancer surgery types for the convenient patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the mean monthly numbers of newly diagnosed gastric cancer patients between the groups
Time Frame: from March 1, 2020 to December 31, 2020 -from January 1, 2019 to December 31, 2019
|
numbers of newly diagnosed gastric cancer
|
from March 1, 2020 to December 31, 2020 -from January 1, 2019 to December 31, 2019
|
Comparison of the clinical staging and pathologic TNM staging of the patients
Time Frame: from March 1, 2020 to December 31, 2020 -from January 1, 2019 to December 31, 2019
|
Clinical staging was determined based on the results of a physical exam, biopsy, and imaging tests including computed tomography (CT), PET CT, endoscopy and the endoscopic ultrasound.
Surgical stage refers to the pathologic stage of the surgical specimen determined based on the American Joint Committee on Cancer (AJCC) TNM system.
|
from March 1, 2020 to December 31, 2020 -from January 1, 2019 to December 31, 2019
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the demographic data
Time Frame: from March 1, 2020 to December 31, 2020 -from January 1, 2019 to December 31, 2019
|
age and gender distributions, mean monthly numbers of newly diagnosed patients, CEA and CEA-19.9
levels, the type of the surgery, the location of the tumor, the frequency of the patients receiving neoadjuvant treatment, American Society of Anesthesiologists (ASA) score, length of the hospital stay,
|
from March 1, 2020 to December 31, 2020 -from January 1, 2019 to December 31, 2019
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ahmet Seker, MD, Adana City Training and Research Hospital
Publications and helpful links
General Publications
- Feletto E, Grogan P, Nickson C, Smith M, Canfell K. How has COVID-19 impacted cancer screening? Adaptation of services and the future outlook in Australia. Public Health Res Pract. 2020 Dec 9;30(4):3042026. doi: 10.17061/phrp3042026.
- Vecchione L, Stintzing S, Pentheroudakis G, Douillard JY, Lordick F. ESMO management and treatment adapted recommendations in the COVID-19 era: colorectal cancer. ESMO Open. 2020 May;5(Suppl 3):e000826. doi: 10.1136/esmoopen-2020-000826.
- Dinmohamed AG, Visser O, Verhoeven RHA, Louwman MWJ, van Nederveen FH, Willems SM, Merkx MAW, Lemmens VEPP, Nagtegaal ID, Siesling S. Fewer cancer diagnoses during the COVID-19 epidemic in the Netherlands. Lancet Oncol. 2020 Jun;21(6):750-751. doi: 10.1016/S1470-2045(20)30265-5. Epub 2020 Apr 30. No abstract available. Erratum In: Lancet Oncol. 2020 May 4;:
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Neoplasms
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- COVID-19
- Coronavirus Infections
- Stomach Neoplasms
Other Study ID Numbers
- 1248
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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