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COVID-19 pandemic and breast cancer management: An observational clinical study from Pakistan

Organizational Data

DRKS-ID:
DRKS00023807
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2020-12-10
Last update in DRKS:
2020-12-10
Registration type:
Retrospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

Brief summary in lay language

COVID-19 outbreak has adversely affected care of breast cancer patients world-wide. There is paucity of available data on cancer management in lower-middle income countries during this pandemic, we sought to determine the institutional approach towards management of breast cancer patients and the outcomes during COVID-19 pandemic at our institution

Brief summary in scientific language

Background: COVID-19 outbreak has adversely affected care of breast cancer patients world-wide. There is paucity of available data on cancer management in lower-middle income countries during this pandemic, we sought to determine the institutional approach towards management of breast cancer patients and the outcomes during COVID-19 pandemic at our institution. Materials and Methods: Clinicopathological and treatment record of cancer patients who presented to the Breast Clinic from 15th March to 31st July 2020 was retrieved from the institutional database for this retrospective clinical observational study. Results: A total of 112 patients were qualified for the analysis in which 66 patients (58.9%) underwent breast cancer surgeries. Only 7 of them (10.6%) were identified to be COVID-19 virus positive on routine pre-operative RT-PCR test before elective surgeries. All were asymptomatic, received home-based care via telecommunication and were operated at a later date when test turned out negative. None of them developed any complications post-operatively. Another group of 44 patients (39.3%) were referred for Neoadjuvant/ Systemic chemotherapy in which COVID-19 infection was detected in only 3 patients (6.8%). Two patients shown symptoms of cough and fever hence hospitalised but were not candidates for Intensive Care Unit admission while the third patient was asymptomatic and isolated at home. All patients recovered well and chemotherapy was commenced again after negative RT-PCR test. No mortality was observed. Conclusion: Despite of being a global crisis particularly for cancer patients we managed to keep infectivity, complications and fatality much lower among breast cancer cases

Health condition or problem studied

Free text:
COVID-19
ICD10:
C50 - Malignant neoplasm of breast
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Patients with Breast cancer presented from March 15 2020 to July 30 20220 were tested for COVID-19 subsequently data was collected on Proforma.

Endpoints

Primary outcome:
COVID 19 Infectivity and associated complications in breast cancer cases.
Secondary outcome:
Overall outcome of breast cancer patients

Study Design

Purpose:
Treatment
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
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Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Pakistan
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Aga Khan University

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2020-03-14
Planned study completion date:
No Entry
Actual Study Completion Date:
2020-10-03
Target Sample Size:
112
Final Sample Size:
112

Inclusion Criteria

Sex:
All
Minimum Age:
23 Years
Maximum Age:
72 Years
Additional Inclusion Criteria:
All Breast cancer patients who presented to Breast Clinic from 15th March to 31st July 2020 which either underwent surgery or referred for Neoadjuvant treatment were included.

Exclusion Criteria

Those patients with incomplete medical records or lost to follow-up were excluded from the analysis

Addresses

Primary Sponsor

Aga Khan University
Assistant Professor Lubna Vohra
National Stadium Rd, Aga Khan University Hospital, Karachi, Pakistan.
74000 Karachi
Pakistan
Telephone:
00923215303685
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Aga khan University
Dr Dua Jabeen
Rafiqui H.J، Iqbal Shaheed Rd, Karachi Cantonment, Karachi,
75850 Karachi
Pakistan
Telephone:
00923212793106
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Aga Khan University
DR Narmeen Asif
National Stadium Rd, Aga Khan University Hospital, Karachi, Pakistan.
74000 Karachi
Pakistan
Telephone:
0092322281056
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Aga khan University
Dr Dua Jabeen
Rafiqui H.J، Iqbal Shaheed Rd, Karachi Cantonment, Karachi,
75850 Karachi
Pakistan
Telephone:
00923212793106
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Aga Khan University Hospital
National Stadium Rd, Aga Khan University Hospital, Karachi, Pakistan.
75850 Karachi
Pakistan
Telephone:
00923215303685
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Aga Khan University (ERC) Pakistan [Aga Khan University (ERC)Pakistan]
Qamar Riaz
National Stadium Rd, Aga Khan University Hospital, Karachi, Pakistan.
74000 Karachi
Pakistan
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
https://www.aku.edu/mcpk/research/Pages/ethical-review.aspx

Vote of leading Ethics Committee

Date of ethics committee application:
2020-08-31
Ethics committee number:
2020-5418-14043
Vote of the Ethics Committee:
No approval required according to the EC
Date of the vote:
2020-10-02

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
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Study abstract:
No Entry
Other study documents:
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Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
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Brief summary of results:
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