NCT04750018

Brief Summary

To assess whether the COVID-19 pandemic delayed breast cancer diagnosis in Taiwan, an Asian country with a low COVID-19 incidence.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 3, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

February 6, 2021

Last Update Submit

February 6, 2021

Conditions

Keywords

COVID-19Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • breast cancer

    Breast cancer or not

    1 year

Study Arms (2)

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.

Other: surgery

Interventions

surgeryOTHER

Patients were divided into surgery and no disease.

COVID-19 2020

Eligibility Criteria

Age30 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Receiving breast exam 2019-2020

You may not qualify if:

  • lost clinical follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiology depart

Kaohsiung City, 813, Taiwan

RECRUITING

Related Publications (2)

  • 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.

  • Chou 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.

MeSH Terms

Conditions

COVID-19Breast Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Chen-Pin Chou, MD

    Kaohsiung Veterans General Hospital.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen-Pin Chou, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Radiologist

Study Record Dates

First Submitted

February 6, 2021

First Posted

February 11, 2021

Study Start

July 3, 2020

Primary Completion

September 28, 2020

Study Completion

June 1, 2021

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

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.

Locations