Trial document




This trial has been registered retrospectively.
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  DRKS00023807

Trial Description

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Title

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

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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

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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

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Do you plan to share individual participant data with other researchers?

No

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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
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Secondary IDs

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Health Condition or Problem studied

  •   COVID-19
  •   C50 -  Malignant neoplasm of breast
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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.
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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
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Primary Outcome

COVID 19 Infectivity and associated complications in breast cancer cases.

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Secondary Outcome

Overall outcome of breast cancer patients

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Countries of Recruitment

  •   Pakistan
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/03/14
  •   112
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   23   Years
  •   72   Years
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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.

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Exclusion Criteria

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

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Addresses

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    • Aga Khan University
    • Ms.  Assistant Professor  Lubna  Vohra 
    • National Stadium Rd, Aga Khan University Hospital, Karachi, Pakistan.
    • 74000  Karachi
    • Pakistan
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    • Aga khan University
    • Mr.  Dr  Dua  Jabeen 
    • Rafiqui H.J، Iqbal Shaheed Rd, Karachi Cantonment, Karachi,
    • 75850  Karachi
    • Pakistan
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    • Aga Khan University
    • Ms.  DR  Narmeen  Asif 
    • National Stadium Rd, Aga Khan University Hospital, Karachi, Pakistan.
    • 74000  Karachi
    • Pakistan
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Sources of Monetary or Material Support

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    • Aga Khan University Hospital
    • Ms.  Assistant Professor  Lubna  Vohra 
    • National Stadium Rd, Aga Khan University Hospital, Karachi, Pakistan.
    • 75850  Karachi
    • Pakistan
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Status

  •   Recruiting complete, follow-up complete
  •   2020/10/03
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Trial Publications, Results and other Documents

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