Ethnic Predisposition, Risk Factors & Breast Cancer Presentation.

Breast Cancer Clinical Trial

— BC  

Official title:

Ethnic Predisposition, Risk Factors & Breast Cancer Presentation; a 10 Year Data. Single Centered Prospective Cohort Study From Karachi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05458570
• Other study ID #: BahriaUni
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2022
• Source: Bahria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Breast cancer, a leading cause of mortality among females, has been the center of research for many decades. Work is in progress to further advance the research worldwide and in our region. This study is conducted to look into regional ethical predilection, clinical presentation/stage, pathological subtypes & risk factors of BC among patients of Karachi, with the aim of proposing a ground to policy making regarding protocol setting for screening and management of BC for our region.

Description:

Background Breast cancer, a leading cause of mortality among females, has been the center of research for many decades. Work is in progress to further advance the research worldwide and in our region. This study is conducted to look into regional ethical predilection, clinical presentation/stage, pathological subtypes & risk factors of BC among patients of Karachi, with the aim of proposing a ground to policy making regarding protocol setting for screening and management of BC for our region.

Methods A prospective cohort single-centered study conducted, which included 500 female patients who attended one surgical unit of a tertiary care public hospital Karachi, during the period of 2010 - 2020. The study was performed in line with the principles of the Declaration of Helsinki and data collection started after taking hospital ethical review board's approval because personal data of patients was used. Afterwards, informed written consent was taken from every included patient. Prior to collecting data, all researchers were thoroughly trained with regards to data collection and examination of patients to eliminate observer bias. Non probability consecutive sampling technique was used. The allotted patients were followed by same researcher from presentation till the end of follow up to avoid observer bias; through direct patient interaction in OPDs and wards, radiological and histo-pathological results from investigations performed and regular follow up of patients during the complete disease period. The retrieved information was filled on pre designed pro-forma. Patients were preemptively explained about our reason for collecting data and its implications. The study is reported according to STROCSS 2021 guidelines.15 Our inclusion criteria was ; female sex, age ≥ 20 years, patients with availability of complete clinical details, biopsy proven breast cancer, no previous history of breast cancer treatment from other centers, all regional ethnicities(residents of Karachi, Sindh only) and all stages of breast cancer. Exclusion criteria of the study was; previously treated breast cancer patients, recurrent BC, female ≤19 years, male/transgender, females coming for treatment from other provinces/foreigners.

Thorough history of all patients obtained including relevant risk factors; i-e age, family history of BC, marital status, age at first born baby, parity, age of menarche/menopause, socio-economic status and ethnicity. Detailed physical examination including clinical presentation of breast lump, its size, side (right/left breast) and site, nipple discharge, nipple retraction, skin involvement, fixity to underlying structures, and lymph node status, was carried out in each patient by a single examiner. Patients presenting with a discrete lump, nipple discharge, nipple changes, skin changes, palpable axillary lymph nodes were subjected to further investigation. Ultrasonography and mammogram of the breast, where possible, were performed as initial imaging modality. FNAC/Biopsy, was carried out in all patients to confirm the diagnosis of BC, its subtype and receptors status. For staging; x-ray chest, ultrasound abdomen for liver and pelvis/ CT chest & abdomen were done on case based need. Bone scan was performed in only symptomatic cases. After thorough overall assessment, clinical stage of BC was assigned to each patient, and stage based treatment was carried out in every patient. Patients having localized disease (≤stage 2A) underwent surgical intervention first followed by chemo/radiotherapy, regional disease(≥ stage 2B) had neo-adjuvant followed by surgery, and advanced disease(stage 4) were given palliation.16 Post operatively detailed histological report of specimen and microscopic involvement of the lymph nodes status were also noted.

Primary outcomes of the cohort were age, ethnicity, family history, stage/histological type and menopausal status while secondary outcomes were parity, marriage, symptoms, lump size/site and socioeconomic status. After collecting the required data on pro forma, it was analyzed using descriptive statistics by SPSS version 23.0 software. With sample size of 500, co-operation rate was 100% and our confidence interval was 97.5% with 5% margin of error. For quantitative data, mean and standard deviation were calculated. Qualitative results were calculated in percentages and presented in tabular forms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Gender: Female
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• female sex, age = 20 years, patients with availability of complete clinical details, biopsy proven breast cancer, no previous history of breast cancer treatment from other centers, males, all regional ethnicities(residents of Karachi, Sindh) and all stages of breast cancer

Exclusion Criteria:

• previously treated breast cancer patients, female =19 years, male/transgender, females coming for treatment for other provinces/foreigners.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Disease Susceptibility

Intervention

Other:
• Breast Cancer positive patients

Locations

Country	Name	City	State
Pakistan	Bahria University Medical and Dental College Karachi	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Bahria University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age	Age range assessed as compare to other studies and included range from 20 years till 85 years, because majority of cases fall in this category	10 years
Primary	Ethnicity	different ethnic groups residing in Karachi were assessed, based on city population data on different ethnicities living in the city	10 years
Primary	Stage of tumor at presentation	Staging of the tumor done according to NCCN guidelines	10 years
Primary	Breast cancer subtype	breast cancer subtype identified according to classification data available on subtypes, based on histopathology	10 years
Primary	Family History	family history data acquired by asking direct questions through the patients. One or more positive relatives with breast cancer in the family were labelled as family history positive patients	10 Years
Primary	Menopausal status	menopausal status was asked by patients if they not have had their last period since last 12 months. 12 months period criteria was set	10 year
Secondary	Risk factors, marital status, parity, symptoms, lump size and site at presentation	secondary outcomes were studied to look for relation of breast cancer with marital status, parity/number of children, symptoms, lump size and site on presentation	10 years