Clinical trial NCT04797624: Does Coronavirus Disease 2019 (COVID-19) Pandemic Cause a Delay in the Diagnosis of Gastric Cancer Patients?
Official title: Does Coronavirus Disease 2019 (COVID-19) Pandemic Cause a Delay in the Diagnosis of Gastric Cancer Patients?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stomach Cancer
Corona Virus Infection
Keywords: gastric surgery
COVID-19
SARS-COV-2
pandemic
stomach surgery
cancer surgery
Lead sponsor: Adana City Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newly diagnosed gastric cancer patients

Brief summary: The aim of this study is to analyze whether COVID-19 causes a delay in the diagnosis of gastric cancer patients particularly in the TNM staging of the tumor, or not and to compare the number of newly diagnosed patients with gastric cancer before and during the COVID-19 pandemic period.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the mean monthly numbers of newly diagnosed gastric cancer patients between the groups
timeFrame: from March 1, 2020 to December 31, 2020 -from January 1, 2019 to December 31, 2019
measure: Comparison of the clinical staging and pathologic TNM staging of the patients
timeFrame: from March 1, 2020 to December 31, 2020 -from January 1, 2019 to December 31, 2019
Secondary outcomes:
measure: Comparison of the demographic data
timeFrame: from March 1, 2020 to December 31, 2020 -from January 1, 2019 to December 31, 2019
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana City Training and Research Hospital
state: Yuregir
Study officials:
affiliation: Adana City Training and Research Hospital
name: Ahmet Seker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.