Does Coronavirus Disease 2019 (COVID-19) Pandemic Cause a Delay in the Diagnosis of Gastric Cancer Patients?

Corona Virus Infection Clinical Trial

Official title:

Does Coronavirus Disease 2019 (COVID-19) Pandemic Cause a Delay in the Diagnosis of Gastric Cancer Patients?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04797624
• Other study ID #: 1248
• Status: Completed
• Start date: January 15, 2021
• Est. completion date: February 15, 2021

Study information

• Verified date: March 2021
• Source: Adana City Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• Severe Acute Respiratory Syndrome
• Stomach Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Gastric cancer surgery
Appropriate gastric cancer surgery types for the convenient patients

Locations

Country	Name	City	State
Turkey	Adana City Training and Research Hospital	Adana	Yuregir

Sponsors (1)

Lead Sponsor	Collaborator
Adana City Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Erratum in: Lancet Oncol. 2020 May 4;:. — View Citation

Feletto E, Grogan P, Dickson 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). pii: 3042026. doi: 10.17061/phrp3042026. — View 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). pii: e000826. doi: 10.1136/esmoopen-2020-000826. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the mean monthly numbers of newly diagnosed gastric cancer patients between the groups	numbers of newly diagnosed gastric cancer	from March 1, 2020 to December 31, 2020 -from January 1, 2019 to December 31, 2019
Primary	Comparison of the clinical staging and pathologic TNM staging of the patients	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
Secondary	Comparison of the demographic data	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