Covid19COVID-19NCT04929964
COVID-19 Pandemic: Effect on Management of Patients With Breast Cancer
An observational study of Covid19 and Breast Cancer Stage, run by Mehwish Mooghal , MBBS at 1 site in Pakistan.
Trial summary
The objective was to find out the impact of COVID-19 on stage of breast cancer at presentation and its effects on overall onco-surgical management. The investigator carried out this research to see the presenting stage of breast cancer in the participants in this pandemic and correlate its effect on stage of breast… Read more about this study
- Who is it for?
- Ages 25 to 71 years, women only
- Conditions the study is for
- Covid19, Breast Cancer Stage, Isolation, Social
- What is being tested?
- MRM , Toilet Mastectomy , BCS
- Type of treatment
- Surgery or procedure
- How many people
- 87 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2020to 31 Jan 2021
- How long will I take part?
- 18 Months
- 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 25 to 71 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patient's data of all operated cases for suspicious lump breast (abnormal findings on ultrasound and mammogram, BIRAD III or above and abnormal FNAC results;C3 or above) from January1,2020 to 31 January 2021was retrieved. Out of these only those patients were included in whom the diagnosis of breast cancer was confirmed on histo-pathological examination. Patients who had already had their surgery pre covid (December 2019), were excluded. Data were collected on standard pre-designed questionnaire and from paper documents retrieved from patient records. All patients who were admitted and underwent pre anesthesia assessment underwent COVID testing according to the protocol.
Who may be able to join
- diagnosis of breast cancer confirmed on histo-pathological examination
Who cannot join
- Patients who had already had their surgery pre covid (December 2019)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bahria University Medical and Dental College Karachi
Karachi, Sindh, 74800
About this study
Official title: COVID 19 Pandemic: Effect on Management of Patients With Breast Cancer; Single Center Study
The objective was to find out the impact of COVID-19 on stage of breast cancer at presentation and its effects on overall onco-surgical management. The investigator carried out this research to see the presenting stage of breast cancer in the participants in this pandemic and correlate its effect on stage of breast cancer and upstaging of disease
Read the detailed description
This retrospective observational study was conducted at department of surgery PNS Shifa hospital Karachi after obtaining permission from ethical review committee. Participant's data of all operated cases for suspicious lump breast (abnormal findings on ultrasound and mammogram, BIRAD III or above and abnormal FNAC results;C3 or above) from January1,2020 to 31 January 2021 was retrieved. Out of these only those participants were included in whom the diagnosis of breast cancer was confirmed on histo-pathological examination. Participants who had already had their surgery pre covid (December 2019), were excluded. Data were collected on standard pre-designed questionnaire and from paper documents retrieved from patient records. Participant presentation time was calculated as the time interval between the appearance of the first symptoms of breast cancer (day 0) and the date of initial presentation to hospital by patient and consultation for breast symptoms. Time taken for start of treatment was calculated by counting number of days from the first presentation day to hospital until the date when definitive treatment for Carcinoma Breast was initiated (chemo/radio/surgery). Time duration for definitive surgery was counted from the day of first presentation to the hospital till the date surgery was conducted(modified radical mastectomy (MRM)/breast conserving surgery (BCS)/toilet mastectomy).
Presentation 'Delay' was defined as a patient reporting to the hospital for medical advice 30 days after noticing the first possible symptoms of breast cancer while time taken for start of treatment was calculated form time of first presentation to hospital (day 0) till the first day of start of definitive first treatment for breast cancer. The investigator labelled delay in treatment if it was initiated later than 62days .
The questionnaire inquired about the symptoms, date of presentation of the first symptoms, date of first reporting to hospital, reasons for the delayed presentation.
All patients who were admitted and underwent pre anesthesia assessment underwent COVID testing according to the protocol. If the patient turned out COVID positive, their symptoms were noted and the COVID team (infectious disease department) was notified. The quarantine protocol at investigating hospital was, complete isolation for 14 days with one PCR-negative report after completing quarantine, with no residual respiratory symptoms of cough, fever, and shortness of breath. This protocol was followed for all elective breast surgery patients admitted in the hospital. All COVID-positive patients underwent the same treatment protocol as non-COVID patients with regards to management of breast cancer. Patients with early breast cancer (upto stage 2A) underwent modified radical mastectomy/breast conservative surgery first, followed by chemotherapy/radiotherapy, locally advanced cases (stage 2B and above) had neo-adjuvant treatment first followed by surgery, and advanced cases(stage 4/metastatic) underwent palliative treatment.
All the data obtained were analyzed using IBM SPSS 23.0. Descriptive statistics like age were presented as range and means. Categorical data were analyzed using fisher exact test and t-test was applied to numerical data. In all cases, a 95% confidence interval was used and p value <0.05 was considered significant.
- Being tested
- MRM , Toilet Mastectomy , BCS
- Keywords
- Breast Cancer, Covid-19, Modified Radical Mastectomy, Breast Conservation Surgery
- Medical subject headings
- COVID-19, Social Isolation, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRM , Toilet Mastectomy , BCSProcedure or surgery
MRM , modified radical mastectomy : removing breast and axilla toilet mastectomy : palliative removal of tumor load BCS ,Breast conservative surgery
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer | Not described Receives: Procedure: MRM , Toilet Mastectomy , BCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of delay in presentation to hospital
It was time counted from the day when the participant first felt breast symptom on self assessment or during diagnostic workup and than presented for the first time to hospital for diagnostic or treatment workup purpose
Measured: 18 months
Duration of delay in definitive treatment
It was counted from the day of first presentation to hospital till the day of initiation of definitive treatment (chemo/surgery)
Measured: 18 months
Cancer upstaging
It was assessed by reassessing the patient by comparison of disease stage on first time diagnostic workup results and than reassessing the stage of cancer during consecutive visits to hospital , and the effect of delay in treatment and presentation on cancer upstaging of participants related to covid 19 pandemic is evaluated .
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Jan 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Case only
- Time perspective
- Other
- Enrolment
- 87 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Mehwish Mooghal , MBBS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehwish Mooghal , MBBS, Bahria University
- Investigators
- Waseem Ahmad Khan, MBBS, FCPS, Study chair, PNS Shifa Hospital Karachi , HOD department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929964
- Sponsor's protocol ID
- COV-19 BUMDC
- Acronym
- COVID-19
- Status last verified
- Jun 2021
- First submitted
- 13 Jun 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: impact of present covid 19 pandemic on presentation of breast cancer stage and disease upstaging status if patients are covid positive
Publications
Gulzar F, Akhtar MS, Sadiq R, Bashir S, Jamil S, Baig SM. Identifying the reasons for delayed presentation of Pakistani breast cancer patients at a tertiary care hospital. Cancer Manag Res. 2019 Jan 29;11:1087-1096. doi: 10.2147/CMAR.S180388. eCollection 2019.
PubMed 30774437Khan MA, Shafique S, Khan MT, Shahzad MF, Iqbal S. Presentation delay in breast cancer patients, identifying the barriers in North Pakistan. Asian Pac J Cancer Prev. 2015;16(1):377-80. doi: 10.7314/apjcp.2015.16.1.377.
PubMed 25640384Vuagnat P, Frelaut M, Ramtohul T, Basse C, Diakite S, Noret A, Bellesoeur A, Servois V, Hequet D, Laas E, Kirova Y, Cabel L, Pierga JY; Institut Curie Breast Cancer and COVID Group; Bozec L, Paoletti X, Cottu P, Bidard FC. COVID-19 in breast cancer patients: a cohort at the Institut Curie hospitals in the Paris area. Breast Cancer Res. 2020 May 28;22(1):55. doi: 10.1186/s13058-020-01293-8.
PubMed 32460829Elghazawy H, Bakkach J, Zaghloul MS, Abusanad A, Hussein MM, Alorabi M, Eldin NB, Helal T, Zaghloul TM, Venkatesulu BP, Elghazaly H, Al-Sukhun S. Implementation of breast cancer continuum of care in low- and middle-income countries during the COVID-19 pandemic. Future Oncol. 2020 Nov;16(31):2551-2567. doi: 10.2217/fon-2020-0574. Epub 2020 Jul 27.
PubMed 32715776
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID 19 Pandemic: Effect on Management of Patients With Breast Cancer; Single Center Study
- ClinicalTrials.gov ID
- NCT04929964
- Acronym / sponsor ID
- COVID-19 / COV-19 BUMDC
- Keywords
- Breast Cancer, Covid-19, Modified Radical Mastectomy, Breast Conservation Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Mehwish Mooghal , MBBSUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 18 Jun 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.
The objective was to find out the impact of COVID-19 on stage of breast cancer at presentation and its effects on overall onco-surgical management. The investigator carried out this research to see the presenting stage of breast cancer in the participants in this pandemic and correlate its effect on stage of breast cancer and upstaging of disease
Detailed description
This retrospective observational study was conducted at department of surgery PNS Shifa hospital Karachi after obtaining permission from ethical review committee. Participant's data of all operated cases for suspicious lump breast (abnormal findings on ultrasound and mammogram, BIRAD III or above and abnormal FNAC results;C3 or above) from January1,2020 to 31 January 2021 was retrieved. Out of these only those participants were included in whom the diagnosis of breast cancer was confirmed on histo-pathological examination. Participants who had already had their surgery pre covid (December 2019), were excluded. Data were collected on standard pre-designed questionnaire and from paper documents retrieved from patient records. Participant presentation time was calculated as the time interval between the appearance of the first symptoms of breast cancer (day 0) and the date of initial presentation to hospital by patient and consultation for breast symptoms. Time taken for start of treatment was calculated by counting number of days from the first presentation day to hospital until the date when definitive treatment for Carcinoma Breast was initiated (chemo/radio/surgery). Time duration for definitive surgery was counted from the day of first presentation to the hospital till the date surgery was conducted(modified radical mastectomy (MRM)/breast conserving surgery (BCS)/toilet mastectomy).
Presentation 'Delay' was defined as a patient reporting to the hospital for medical advice 30 days after noticing the first possible symptoms of breast cancer while time taken for start of treatment was calculated form time of first presentation to hospital (day 0) till the first day of start of definitive first treatment for breast cancer. The investigator labelled delay in treatment if it was initiated later than 62days .
The questionnaire inquired about the symptoms, date of presentation of the first symptoms, date of first reporting to hospital, reasons for the delayed presentation.
All patients who were admitted and underwent pre anesthesia assessment underwent COVID testing according to the protocol. If the patient turned out COVID positive, their symptoms were noted and the COVID team (infectious disease department) was notified. The quarantine protocol at investigating hospital was, complete isolation for 14 days with one PCR-negative report after completing quarantine, with no residual respiratory symptoms of cough, fever, and shortness of breath. This protocol was followed for all elective breast surgery patients admitted in the hospital. All COVID-positive patients underwent the same treatment protocol as non-COVID patients with regards to management of breast cancer. Patients with early breast cancer (upto stage 2A) underwent modified radical mastectomy/breast conservative surgery first, followed by chemotherapy/radiotherapy, locally advanced cases (stage 2B and above) had neo-adjuvant treatment first followed by surgery, and advanced cases(stage 4/metastatic) underwent palliative treatment.
All the data obtained were analyzed using IBM SPSS 23.0. Descriptive statistics like age were presented as range and means. Categorical data were analyzed using fisher exact test and t-test was applied to numerical data. In all cases, a 95% confidence interval was used and p value <0.05 was considered significant.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer | – | Procedure: MRM , Toilet Mastectomy , BCS |
Who may qualify
- Ages
- 25 to 71 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient's data of all operated cases for suspicious lump breast (abnormal findings on ultrasound and mammogram, BIRAD III or above and abnormal FNAC results;C3 or above) from January1,2020 to 31 January 2021was retrieved. Out of these only those patients were included in whom the diagnosis of breast cancer was confirmed on histo-pathological examination. Patients who had already had their surgery pre covid (December 2019), were excluded. Data were collected on standard pre-designed questionnaire and from paper documents retrieved from patient records. All patients who were admitted and underwent pre anesthesia assessment underwent COVID testing according to the protocol.
Key inclusion criteria (1 listed)
- diagnosis of breast cancer confirmed on histo-pathological examination
Key exclusion criteria (1 listed)
- Patients who had already had their surgery pre covid (December 2019)
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 |
|---|---|---|
| MRM , Toilet Mastectomy , BCSMRM , modified radical mastectomy : removing breast and axilla toilet mastectomy : palliative removal of tumor load BCS ,Breast conservative surgery | Procedure or surgery | Breast cancer |
Primary outcome
Duration of delay in presentation to hospital
Time frame: 18 months
It was time counted from the day when the participant first felt breast symptom on self assessment or during diagnostic workup and than presented for the first time to hospital for diagnostic or treatment workup purpose
Duration of delay in definitive treatment
Time frame: 18 months
It was counted from the day of first presentation to hospital till the day of initiation of definitive treatment (chemo/surgery)
Cancer upstaging
Time frame: 18 months
It was assessed by reassessing the patient by comparison of disease stage on first time diagnostic workup results and than reassessing the stage of cancer during consecutive visits to hospital , and the effect of delay in treatment and presentation on cancer upstaging of participants related to covid 19 pandemic is evaluated .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Background: PubMed 30774437Gulzar F, Akhtar MS, Sadiq R, Bashir S, Jamil S, Baig SM. Identifying the reasons for delayed presentation of Pakistani breast cancer patients at a tertiary care hospital. Cancer Manag Res. 2019 Jan 29;11:1087-1096. doi: 10.2147/CMAR.S180388. eCollection 2019.
- Background: PubMed 25640384Khan MA, Shafique S, Khan MT, Shahzad MF, Iqbal S. Presentation delay in breast cancer patients, identifying the barriers in North Pakistan. Asian Pac J Cancer Prev. 2015;16(1):377-80. doi: 10.7314/apjcp.2015.16.1.377.
- Background: PubMed 32460829Vuagnat P, Frelaut M, Ramtohul T, Basse C, Diakite S, Noret A, Bellesoeur A, Servois V, Hequet D, Laas E, Kirova Y, Cabel L, Pierga JY; Institut Curie Breast Cancer and COVID Group; Bozec L, Paoletti X, Cottu P, Bidard FC. COVID-19 in breast cancer patients: a cohort at the Institut Curie hospitals in the Paris area. Breast Cancer Res. 2020 May 28;22(1):55. doi: 10.1186/s13058-020-01293-8.
- Results publication: PubMed 32715776Elghazawy H, Bakkach J, Zaghloul MS, Abusanad A, Hussein MM, Alorabi M, Eldin NB, Helal T, Zaghloul TM, Venkatesulu BP, Elghazaly H, Al-Sukhun S. Implementation of breast cancer continuum of care in low- and middle-income countries during the COVID-19 pandemic. Future Oncol. 2020 Nov;16(31):2551-2567. doi: 10.2217/fon-2020-0574. Epub 2020 Jul 27.
- Individual participant dataSharing planned: Yes. impact of present covid 19 pandemic on presentation of breast cancer stage and disease upstaging status if patients are covid positive
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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.
Waseem Ahmad Khan, MBBS, FCPS study chair
PNS Shifa Hospital Karachi , HOD department of Surgery
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 Covid19 and Breast Cancer Stage, run by Mehwish Mooghal , MBBS at 1 site in Pakistan.
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: finished, as of the sponsor's last update on 11 Aug 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of delay in presentation to hospital (time frame: 18 months). The study lists 3 primary outcomes in all. 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 NCT04929964, which also lists 4 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 Aug 2021.