Stomach CancerNCT04797624
Does Coronavirus Disease 2019 (COVID-19) Pandemic Cause a Delay in the Diagnosis of Gastric Cancer Patients?
An observational study of Stomach Cancer and Corona Virus Infection, run by Adana City Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Stomach Cancer, Corona Virus Infection
- What is being tested?
- Gastric cancer surgery
- Type of treatment
- Surgery or procedure
- How many people
- 146 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2021to 15 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: newly diagnosed gastric cancer patients
Who may be able to join
- Patients newly diagnosed with gastric cancer at specified intervals will be included in the study.
Who cannot join
- Having an additional second primary tumor
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adana City Training and Research Hospital
Adana, Yuregir, 01370
About this study
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.
Read the 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.
- Conditions
- Stomach Cancer, Corona Virus Infection
- Being tested
- Gastric cancer surgery
- Keywords
- gastric surgery, COVID-19, SARS-COV-2, pandemic, stomach surgery, cancer surgery
- Medical subject headings
- Stomach Neoplasms, Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric cancer surgeryProcedure or surgery
Appropriate gastric cancer surgery types for the convenient patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Gastric cancer surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the mean monthly numbers of newly diagnosed gastric cancer patients between the groups
numbers of newly diagnosed gastric cancer
Measured: 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.
Measured: from March 1, 2020 to December 31, 2020 -from January 1, 2019 to December 31, 2019
Secondary outcomes (1)
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,
Measured: from March 1, 2020 to December 31, 2020 -from January 1, 2019 to December 31, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start15 Jan 2021
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stomach CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adana City Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Şeker, Adana City Training and Research Hospital
- Investigators
- Ahmet Seker, MD, Principal investigator, Adana City Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797624
- Sponsor's protocol ID
- 1248
- Status last verified
- Mar 2021
- First submitted
- 12 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33294902Vecchione 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.
PubMed 32457036Dinmohamed 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.
PubMed 32359403
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Coronavirus Disease 2019 (COVID-19) Pandemic Cause a Delay in the Diagnosis of Gastric Cancer Patients?
- ClinicalTrials.gov ID
- NCT04797624
- Acronym / sponsor ID
- 1248
- Conditions
- Stomach Cancer, Corona Virus Infection
- Keywords
- gastric surgery, COVID-19, SARS-COV-2, pandemic, stomach surgery, cancer surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Adana City Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline group | – | Procedure: Gastric cancer surgeryThe 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. |
| Pandemic group | – | Procedure: Gastric cancer surgeryThe 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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- newly diagnosed gastric cancer patients
Key inclusion criteria (1 listed)
- Patients newly diagnosed with gastric cancer at specified intervals will be included in the study.
Key exclusion criteria (1 listed)
- Having an additional second primary tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric cancer surgeryAppropriate gastric cancer surgery types for the convenient patients | Procedure or surgery | Baseline group, Pandemic group |
Primary outcome
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
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.
1 secondary outcome
Comparison of the demographic data
Time frame: from March 1, 2020 to December 31, 2020 -from January 1, 2019 to December 31, 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Background: PubMed 33294902Feletto 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.
- Background: PubMed 32457036Vecchione 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.
- Background: PubMed 32359403Dinmohamed 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Seker, MD principal investigator
Adana City Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Cancer and Corona Virus Infection, run by Adana City Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04797624, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.