Ignite Creation Date:
2024-05-06 @ 5:52 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05458570
Status:
COMPLETED
Last Update Posted:
2022-07-14
First Post:
2022-07-09
Brief Title:
Ethnic Predisposition Risk Factors Breast Cancer Presentation
Sponsor:
Bahria University
Organization:
Bahria University
Study Overview
Official Title:
Ethnic Predisposition Risk Factors Breast Cancer Presentation a 10 Year Data Single Centered Prospective Cohort Study From Karachi
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BC
Brief 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 presentationstage 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
Detailed 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 presentationstage 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 boards 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 guidelines15 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 ethnicitiesresidents 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 maletransgender females coming for treatment from other provincesforeigners
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 menarchemenopause socio-economic status and ethnicity Detailed physical examination including clinical presentation of breast lump its size side rightleft 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 FNACBiopsy 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 chemoradiotherapy regional disease stage 2B had neo-adjuvant followed by surgery and advanced diseasestage 4 were given palliation16 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 stagehistological type and menopausal status while secondary outcomes were parity marriage symptoms lump sizesite and socioeconomic status After collecting the required data on pro forma it was analyzed using descriptive statistics by SPSS version 230 software With sample size of 500 co-operation rate was 100 and our confidence interval was 975 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
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 boards 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 guidelines15 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 ethnicitiesresidents 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 maletransgender females coming for treatment from other provincesforeigners
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 menarchemenopause socio-economic status and ethnicity Detailed physical examination including clinical presentation of breast lump its size side rightleft 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 FNACBiopsy 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 chemoradiotherapy regional disease stage 2B had neo-adjuvant followed by surgery and advanced diseasestage 4 were given palliation16 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 stagehistological type and menopausal status while secondary outcomes were parity marriage symptoms lump sizesite and socioeconomic status After collecting the required data on pro forma it was analyzed using descriptive statistics by SPSS version 230 software With sample size of 500 co-operation rate was 100 and our confidence interval was 975 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None