COVID-19NCT04750018
Influence of Co-Vid 19 Pandemic on Screening Mammography Single Institution
An observational study of COVID-19 and Breast Cancer, run by Chen-Pin Chou at 1 site in Taiwan.
Trial summary
To assess whether the COVID-19 pandemic delayed breast cancer diagnosis in Taiwan, an Asian country with a low COVID-19 incidence. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- COVID-19, Breast Cancer
- What is being tested?
- surgery
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jul 2020to 1 Jun 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 30 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The test period of the COVID-19 pandemic was between January 1 and July 31, 2020. Moreover, the control period of the pre-COVID-19 pandemic was between January 1 and July 31, 2019, before there was any report about the virus. Only patients with complete medical records were eligible for enrollment in this study. Confirmed COVID-19 case numbers in Taiwan were acquired from Taiwan's National Health Command Center [7]. Anonymized records of breast biopsies and cancer registration in a single institution in southern Taiwan in the pre-COVID-19 and COVID-19 periods were reviewed.
Who may be able to join
- Receiving breast exam 2019-2020
Who cannot join
- lost clinical follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Co-Vid 19 Pandemic on Screening Mammography in a Single Institution
To assess whether the COVID-19 pandemic delayed breast cancer diagnosis in Taiwan, an Asian country with a low COVID-19 incidence.
Read the detailed description
The institutional review board approved this retrospective study at a public academic medical center. The monthly volume of breast biopsies and breast cancers during the COVID-19 pandemic (between January 1 and July 31, 2020) was compared to the same period a year earlier (pre-COVID-19).
- Conditions
- COVID-19, Breast Cancer
- Being tested
- surgery
- Keywords
- COVID-19, Breast Cancer
- Medical subject headings
- COVID-19, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryOther
Patients were divided into surgery and no disease.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 2019 | Patients receiving biopsies with a BI-RADS assessment of 4 or 5 from mammographic or ultrasonographic exams or combinations of tests were analyzed [4]. We further categorized the biopsy data as ultrasound-guided or mammograph-guided biopsy based on procedure coding. Ultrasound-guided core needle biopsy (CNB) was performed for breast lesions visible on ultrasound. | |
| COVID-19 2020 | Patients receiving biopsies with a BI-RADS assessment of 4 or 5 from mammographic or ultrasonographic exams or combinations of tests were analyzed [4]. We further categorized the biopsy data as ultrasound-guided or mammograph-guided biopsy based on procedure coding. Ultrasound-guided core needle biopsy (CNB) was performed for breast lesions visible on ultrasound. Receives: Other: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast cancer
Breast cancer or not
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start3 Jul 2020
- Primary completion28 Sep 2020
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen-Pin Chou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen-Pin Chou, Kaohsiung Veterans General Hospital.
- Investigators
- Chen-Pin Chou, MD, Principal investigator, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750018
- Sponsor's protocol ID
- KSVGH20-CT7-26
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available on reasonable request from the corresponding author. Some data are not publicly available due to their containing information that could compromise the privacy of research participants.
Publications
Chou CP, Pan HB, Yang TL, Chiang CL, Huang JS, Tsai MY. Impact of the COVID-19 pandemic on the volume of mammography examinations in Southern Taiwan. Breast J. 2021 Jan;27(1):89-91. doi: 10.1111/tbj.14019. Epub 2020 Aug 20. No abstract available.
PubMed 32815587Chou CP, Lin HS. Delayed Breast Cancer Detection in an Asian Country (Taiwan) with Low COVID-19 Incidence. Cancer Manag Res. 2021 Jul 28;13:5899-5906. doi: 10.2147/CMAR.S314282. eCollection 2021.
PubMed 34349563
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Co-Vid 19 Pandemic on Screening Mammography in a Single Institution
- ClinicalTrials.gov ID
- NCT04750018
- Acronym / sponsor ID
- KSVGH20-CT7-26
- Conditions
- COVID-19, Breast Cancer
- Keywords
- COVID-19, Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Chen-Pin ChouUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 11 Feb 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.
To assess whether the COVID-19 pandemic delayed breast cancer diagnosis in Taiwan, an Asian country with a low COVID-19 incidence.
Detailed description
The institutional review board approved this retrospective study at a public academic medical center. The monthly volume of breast biopsies and breast cancers during the COVID-19 pandemic (between January 1 and July 31, 2020) was compared to the same period a year earlier (pre-COVID-19).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 2019 | – | –Patients receiving biopsies with a BI-RADS assessment of 4 or 5 from mammographic or ultrasonographic exams or combinations of tests were analyzed [4]. We further categorized the biopsy data as ultrasound-guided or mammograph-guided biopsy based on procedure coding. Ultrasound-guided core needle biopsy (CNB) was performed for breast lesions visible on ultrasound. |
| COVID-19 2020 | – | Other: surgeryPatients receiving biopsies with a BI-RADS assessment of 4 or 5 from mammographic or ultrasonographic exams or combinations of tests were analyzed [4]. We further categorized the biopsy data as ultrasound-guided or mammograph-guided biopsy based on procedure coding. Ultrasound-guided core needle biopsy (CNB) was performed for breast lesions visible on ultrasound. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The test period of the COVID-19 pandemic was between January 1 and July 31, 2020. Moreover, the control period of the pre-COVID-19 pandemic was between January 1 and July 31, 2019, before there was any report about the virus. Only patients with complete medical records were eligible for enrollment in this study. Confirmed COVID-19 case numbers in Taiwan were acquired from Taiwan's National Health Command Center [7]. Anonymized records of breast biopsies and cancer registration in a single institution in southern Taiwan in the pre-COVID-19 and COVID-19 periods were reviewed.
Key inclusion criteria (1 listed)
- Receiving breast exam 2019-2020
Key exclusion criteria (1 listed)
- lost clinical follow-up
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 |
|---|---|---|
| surgeryPatients were divided into surgery and no disease. | Other | COVID-19 2020 |
Primary outcome
breast cancer
Time frame: 1 year
Breast cancer or not
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Results publication: PubMed 32815587Chou CP, Pan HB, Yang TL, Chiang CL, Huang JS, Tsai MY. Impact of the COVID-19 pandemic on the volume of mammography examinations in Southern Taiwan. Breast J. 2021 Jan;27(1):89-91. doi: 10.1111/tbj.14019. Epub 2020 Aug 20. No abstract available.
- Derived from this study: PubMed 34349563Chou CP, Lin HS. Delayed Breast Cancer Detection in an Asian Country (Taiwan) with Low COVID-19 Incidence. Cancer Manag Res. 2021 Jul 28;13:5899-5906. doi: 10.2147/CMAR.S314282. eCollection 2021.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available on reasonable request from the corresponding author. Some data are not publicly available due to their containing information that could compromise the privacy of research participants.
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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.
Chen-Pin Chou, MD principal investigator
Kaohsiung Veterans General 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 COVID-19 and Breast Cancer, run by Chen-Pin Chou at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 11 Feb 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen-Pin Chou, MD (*886-3422121 ext. 6524, chouchenpin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
breast cancer (time frame: 1 year). 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 NCT04750018, which also lists 2 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 11 Feb 2021.