Trial document
This trial has been registered retrospectively.
DRKS00023807
Trial Description
Title
COVID-19 pandemic and breast cancer management: An observational clinical study from Pakistan
Trial Acronym
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URL of the Trial
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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
Do you plan to share individual participant data with other researchers?
No
Description IPD sharing plan:
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Organizational Data
- DRKS00023807
- 2020/12/10
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- yes
- No approval required according to EC
- 2020-5418-14043, Aga Khan University (ERC)Pakistan
Secondary IDs
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Health Condition or Problem studied
- COVID-19
- C50 - Malignant neoplasm of breast
Interventions/Observational Groups
- Patients with Breast cancer presented from March 15 2020 to July 30 20220 were tested for COVID-19 subsequently data was collected on Proforma.
Characteristics
- Non-interventional
- Observational study
- Single arm study
- Open (masking not used)
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- Uncontrolled/Single arm
- Treatment
- Single (group)
- N/A
- No
Primary Outcome
COVID 19 Infectivity and associated complications in breast cancer cases.
Secondary Outcome
Overall outcome of breast cancer patients
Countries of Recruitment
- Pakistan
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2020/03/14
- 112
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 23 Years
- 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
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start of 1:1-Block address primary-sponsor
- Aga Khan University
- Ms. Assistant Professor Lubna Vohra
- National Stadium Rd, Aga Khan University Hospital, Karachi, Pakistan.
- 74000 Karachi
- Pakistan
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 00923215303685
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- lubna_mushtaque at hotmail.com
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end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Aga khan University
- Mr. Dr Dua Jabeen
- Rafiqui H.J، Iqbal Shaheed Rd, Karachi Cantonment, Karachi,
- 75850 Karachi
- Pakistan
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 00923212793106
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- jabeen_dua at hotmail.com
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end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Aga Khan University
- Ms. DR Narmeen Asif
- National Stadium Rd, Aga Khan University Hospital, Karachi, Pakistan.
- 74000 Karachi
- Pakistan
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0092322281056
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- narmeen.asif at aku.edu
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end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Aga Khan University Hospital
- Ms. Assistant Professor Lubna Vohra
- National Stadium Rd, Aga Khan University Hospital, Karachi, Pakistan.
- 75850 Karachi
- Pakistan
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 00923215303685
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- lubna_mushtaque at hotmail.com
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end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2020/10/03
Trial Publications, Results and other Documents
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