NCT04797624

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

1 month

First QC Date

March 12, 2021

Last Update Submit

March 12, 2021

Conditions

Keywords

gastric surgeryCOVID-19SARS-COV-2pandemicstomach surgerycancer surgery

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Comparison of the demographic data

    from March 1, 2020 to December 31, 2020 -from January 1, 2019 to December 31, 2019

Study Arms (2)

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.

Procedure: Gastric cancer surgery

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.

Procedure: Gastric cancer surgery

Interventions

Appropriate gastric cancer surgery types for the convenient patients

Baseline groupPandemic group

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

newly diagnosed gastric cancer patients

You may qualify if:

  • Patients newly diagnosed with gastric cancer at specified intervals will be included in the study.

You may not qualify if:

  • Having an additional second primary tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adana City Training and Research Hospital

Adana, Yuregir, 01370, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 33294902BACKGROUND
  • 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.

    PMID: 32457036BACKGROUND
  • 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.

    PMID: 32359403BACKGROUND

MeSH Terms

Conditions

Stomach NeoplasmsCoronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ahmet Seker, MD

    Adana City Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ahmet Seker, Associate Professor, MD, Department of Gastroenterological Surgery

Study Record Dates

First Submitted

March 12, 2021

First Posted

March 15, 2021

Study Start

January 15, 2021

Primary Completion

February 15, 2021

Study Completion

February 15, 2021

Last Updated

March 15, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations