COVID-19 Pandemic: Effect on Management of Patients With Breast Cancer

NCT04929964 | Completed DMC

• 1 other identifier: COV-19 BUMDC
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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 cancer and upstaging of disease

Conditions

Covid19; Breast Cancer Stage; Isolation, Social; Locally Advanced Breast Cancer

Keywords

Breast Cancer; Covid-19; Modified Radical Mastectomy; Breast Conservation Surgery

Outcome Measures

Primary Outcomes (3)

• 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

  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)

  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 .

  18 months

Study Arms (1)

Breast cancer

Procedure: MRM , Toilet Mastectomy , BCS

Interventions

MRM , Toilet Mastectomy , BCS PROCEDURE

MRM , modified radical mastectomy : removing breast and axilla toilet mastectomy : palliative removal of tumor load BCS ,Breast conservative surgery

Breast cancer

Eligibility Criteria

• Age: 25 Years - 71 Years
• Gender Eligibility Details: Breast cancer incidence is more in females as compare to male population
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• diagnosis of breast cancer confirmed on histo-pathological examination

You may not qualify if:

• Patients who had already had their surgery pre covid (December 2019)

Sponsors & Collaborators

• Mehwish Mooghal , MBBS: lead

Study Sites (1)

Bahria University Medical and Dental College Karachi

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 30774437 BACKGROUND

• Khan 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.

  PMID: 25640384 BACKGROUND

• Vuagnat 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.

  PMID: 32460829 BACKGROUND

• Elghazawy 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.

  PMID: 32715776 RESULT

MeSH Terms

Conditions

COVID-19; Social Isolation; Breast Neoplasms

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Social Behavior; Behavior; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• Waseem Ahmad Khan, MBBS, FCPS

  PNS Shifa Hospital Karachi , HOD department of Surgery

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Surgery at PNS Shifa Hospital Karachi

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: June 18, 2021
• Study Start: January 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

PA (1)