Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403917
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-27
Brief Title:
Evaluation of Breast Cancer Screening Program at Assiut Governorate
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Evaluation of Breast Cancer Screening Program in Assiut Governorate Egyptian Women Health Initiative
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
1 To evaluate the ability of breast clinical examination as screening tool to detect early and advanced stages of breast cancer
2 To determine the percentage of breast cancer confirmed cases among women screened at women health campaign in Assiut governorate
3 To determine drop out from referral system among screening program
4 Identify the healthcare providers knowledge about breast cancer and screening tools perception practice and barriers in delivering the program
2 To determine the percentage of breast cancer confirmed cases among women screened at women health campaign in Assiut governorate
3 To determine drop out from referral system among screening program
4 Identify the healthcare providers knowledge about breast cancer and screening tools perception practice and barriers in delivering the program
Detailed Description:
Breast cancer is the most frequently diagnosed cancer and the leading cause of cancer death in females worldwide Despite major efforts at early detection and new treatments breast cancer claims the lives of over 520000 women every year 1 with an estimated 23 million new cancer cases 1 in 4 new cancer cases and 685000 cancer deaths 1 in 6 deaths in 2020
Breast cancer incidence rates varied by nearly 4-fold across WHO areas The highest incidence rates per 100000 were found in AustraliaNew Zealand 955 Western Europe 907 and Northern America 894 while the lowest rates were in South-Central Asia 262 Middle and Eastern Africa 33 and Central America 395 In contrast the highest breast cancer mortality rates were recorded in Melanesia 375 Polynesia and Western Africa 223 and the Caribbean 189 while the lowest rates were found in Eastern Asia 98 Central America 104 and AustraliaNew Zealand standardized breast cancer incidence rate per 100000 increased from 106 1975 to 142 1999 decreased to 128 2004 and then slowly increased to 137 per 100000 in 2019 Similar broad temporal trend patterns were observed in other western countries2 Incidence rates are rising in South America Africa and Asia where rates were historically low Worldwide an estimated 2964197 new female breast cancer cases are projected to occur in 2040 a 31 increase from the corresponding 2260127 cases in 2020 34 Breast Cancer in Arab Countries From available data from the years 2010 2013 and most recently 2020 breast cancer is thought to be the most common malignancy diagnosed in Arab women estimating somewhere between 14-42 of all tumors 5 6in some reports and between 177-19 of all new cancers in others 7 depending on individual countries and type of reports reviewed
In Egypt In Egypt breast cancer is the most common malignancy in women accounting for 388 of cancers in this population with the estimated number of breast cancer cases nearly 22700 in 2020 and forecasted to be approximately 46000 in 2050 It is estimated that the breast cancer mortality rate is around 11 being the second cause of cancer-related mortality after liver cancer9 Early diagnosis in symptomatic populations and screening in asymptomatic populations are the two main components of cancer early-detection programs as defined by the WHO to reduce the incidence of advanced cancer and mortality In low- and middle-income countries where cancer is diagnosed in advanced stages and allocated resources are limited it is highly recommended that cancer control programs include the following elements 1 targeted outreacheducation promotion and 2 efforts to encourage clinical breast examination for at-risk groups with or without opportunistic mammographic screening This is to keep with the goal of downsizing symptomatic disease andor asymptomatic disease in high-risk groups10 Breast self-examination BSE clinical breast examination CBE by a physician and mammography are three instruments recommended for breast cancer screening BSE is highly useful in breast cancer screening as it is cheap easy confidential uncomplicated and without the need for special equipment 11 Clinical Breast Examination CBE is defined as the examination of a womans breasts by a healthcare professional such as a breast surgeon family physician or breast care nurse who is trained to recognize many different types of abnormalities and warning signs in the breast 12 Screening mammography is a low-dose X-ray examination of a womans breasts used to detect BC when that cancer is too small to be felt as a lump Screening mammography is very useful as it reduces mortality from BC by about 20-35 in women aged 50-69 years and slightly less in women aged 40-49 years at a period of 14 years of follow-up 10
In Egypt facilities for mammographic screening are available in the major governmental and private hospitals and delivered through mobile units equipped with digital mammography units Despite these mobile units which increase the presence in rural areas and less affluent areas barriers to accessing mammography still exist 13
Delays to breast cancer treatment of greater than three months have been associated with more advanced disease stage at diagnosis and poorer survival At the same time education of primary care providers to recognize the early signs and symptoms of breast cancer is necessary for prompt referral through the healthcare system 14
A retrospective analysis of cancer screening data from 2012 to 2019 was carried out in Jeddah Saudi Arabia Of the 16000 women invited from 2012 to 2019 a total of 1911 119 participated The majority of women 688 were between 40 and 55 years old Based on the screening process results 266 401 97 13 07 and 52 of women had BI-RADS scores of R1 R2 R3 R4 R5 and R0 respectively The remaining 163 did not have mammogram records The recall rate or the percentage of women who underwent further evaluation was 199 189 underwent a biopsy procedure In addition 16 of women had cancer screen-detected although only 07 were diagnosed with breast cancer15 A case-control study to evaluate the impact of the breast screening program on mortality in England The study dataset had a total of 9550 cases and 17993 controls the main objective was to evaluate the effect of mammography screening on breast cancer mortality This study showed that the breast screening programs in England continues to play an important role in the control of breast cancer The effect of screening within the NHS BSP in England is stronger and longer lasting in women aged 65 or over but it remains highly relevant for younger women 16 In Egypt the first national screening program the Women Health Outreach Program was initiated in October 2007 It was a government-funded program that offered free mammograms for Egyptian women aged 45 and screening for diabetes hypertension and obesity This was approached using mammography vans equipped with a full-field digital mammography machine and a dedicated computer system linked to the National Breast Screening Center Free treatment was offered for cases in which breast cancer was detected From October 2007 to February 2009 20098 women in three governorates were screened for breast cancer1317 Egypt is divided into 27 governorates the highest tier of the countrys jurisdiction hierarchy With the launch of the 100 Million Healthy Lives national initiative more efforts were directed to control breast cancer in Egypt In July 2019 a nationwide campaign was started in 9 governorates Alexandria Port Said Matrouh Qalyubia Beheira Assiut Fayoum South Sinai and Damietta and extended after 2 months to another 11 governorates Cairo North Sinai the Red Sea Ismailia Suez Kafr El-Sheikh Menoufia Beni Suef Sohag Luxor and Aswan and then after 2 more months to the remaining 7 governorates Giza the New Valley Gharbia Dakahlia Sharqia Minya and Qena The main objectives of this campaign are to promote breast cancer awareness and the importance of early diagnosis screening for breast cancer and treatment of diagnosed cases according to recent protocols Suspected cases are referred for further investigation and treatment at no cost for the participants The media center for the Council of Ministers announced that 85 million women had been examined by October 20 2020 from all over Egypt with the aim of reaching 31 million women 18
Breast cancer incidence rates varied by nearly 4-fold across WHO areas The highest incidence rates per 100000 were found in AustraliaNew Zealand 955 Western Europe 907 and Northern America 894 while the lowest rates were in South-Central Asia 262 Middle and Eastern Africa 33 and Central America 395 In contrast the highest breast cancer mortality rates were recorded in Melanesia 375 Polynesia and Western Africa 223 and the Caribbean 189 while the lowest rates were found in Eastern Asia 98 Central America 104 and AustraliaNew Zealand standardized breast cancer incidence rate per 100000 increased from 106 1975 to 142 1999 decreased to 128 2004 and then slowly increased to 137 per 100000 in 2019 Similar broad temporal trend patterns were observed in other western countries2 Incidence rates are rising in South America Africa and Asia where rates were historically low Worldwide an estimated 2964197 new female breast cancer cases are projected to occur in 2040 a 31 increase from the corresponding 2260127 cases in 2020 34 Breast Cancer in Arab Countries From available data from the years 2010 2013 and most recently 2020 breast cancer is thought to be the most common malignancy diagnosed in Arab women estimating somewhere between 14-42 of all tumors 5 6in some reports and between 177-19 of all new cancers in others 7 depending on individual countries and type of reports reviewed
In Egypt In Egypt breast cancer is the most common malignancy in women accounting for 388 of cancers in this population with the estimated number of breast cancer cases nearly 22700 in 2020 and forecasted to be approximately 46000 in 2050 It is estimated that the breast cancer mortality rate is around 11 being the second cause of cancer-related mortality after liver cancer9 Early diagnosis in symptomatic populations and screening in asymptomatic populations are the two main components of cancer early-detection programs as defined by the WHO to reduce the incidence of advanced cancer and mortality In low- and middle-income countries where cancer is diagnosed in advanced stages and allocated resources are limited it is highly recommended that cancer control programs include the following elements 1 targeted outreacheducation promotion and 2 efforts to encourage clinical breast examination for at-risk groups with or without opportunistic mammographic screening This is to keep with the goal of downsizing symptomatic disease andor asymptomatic disease in high-risk groups10 Breast self-examination BSE clinical breast examination CBE by a physician and mammography are three instruments recommended for breast cancer screening BSE is highly useful in breast cancer screening as it is cheap easy confidential uncomplicated and without the need for special equipment 11 Clinical Breast Examination CBE is defined as the examination of a womans breasts by a healthcare professional such as a breast surgeon family physician or breast care nurse who is trained to recognize many different types of abnormalities and warning signs in the breast 12 Screening mammography is a low-dose X-ray examination of a womans breasts used to detect BC when that cancer is too small to be felt as a lump Screening mammography is very useful as it reduces mortality from BC by about 20-35 in women aged 50-69 years and slightly less in women aged 40-49 years at a period of 14 years of follow-up 10
In Egypt facilities for mammographic screening are available in the major governmental and private hospitals and delivered through mobile units equipped with digital mammography units Despite these mobile units which increase the presence in rural areas and less affluent areas barriers to accessing mammography still exist 13
Delays to breast cancer treatment of greater than three months have been associated with more advanced disease stage at diagnosis and poorer survival At the same time education of primary care providers to recognize the early signs and symptoms of breast cancer is necessary for prompt referral through the healthcare system 14
A retrospective analysis of cancer screening data from 2012 to 2019 was carried out in Jeddah Saudi Arabia Of the 16000 women invited from 2012 to 2019 a total of 1911 119 participated The majority of women 688 were between 40 and 55 years old Based on the screening process results 266 401 97 13 07 and 52 of women had BI-RADS scores of R1 R2 R3 R4 R5 and R0 respectively The remaining 163 did not have mammogram records The recall rate or the percentage of women who underwent further evaluation was 199 189 underwent a biopsy procedure In addition 16 of women had cancer screen-detected although only 07 were diagnosed with breast cancer15 A case-control study to evaluate the impact of the breast screening program on mortality in England The study dataset had a total of 9550 cases and 17993 controls the main objective was to evaluate the effect of mammography screening on breast cancer mortality This study showed that the breast screening programs in England continues to play an important role in the control of breast cancer The effect of screening within the NHS BSP in England is stronger and longer lasting in women aged 65 or over but it remains highly relevant for younger women 16 In Egypt the first national screening program the Women Health Outreach Program was initiated in October 2007 It was a government-funded program that offered free mammograms for Egyptian women aged 45 and screening for diabetes hypertension and obesity This was approached using mammography vans equipped with a full-field digital mammography machine and a dedicated computer system linked to the National Breast Screening Center Free treatment was offered for cases in which breast cancer was detected From October 2007 to February 2009 20098 women in three governorates were screened for breast cancer1317 Egypt is divided into 27 governorates the highest tier of the countrys jurisdiction hierarchy With the launch of the 100 Million Healthy Lives national initiative more efforts were directed to control breast cancer in Egypt In July 2019 a nationwide campaign was started in 9 governorates Alexandria Port Said Matrouh Qalyubia Beheira Assiut Fayoum South Sinai and Damietta and extended after 2 months to another 11 governorates Cairo North Sinai the Red Sea Ismailia Suez Kafr El-Sheikh Menoufia Beni Suef Sohag Luxor and Aswan and then after 2 more months to the remaining 7 governorates Giza the New Valley Gharbia Dakahlia Sharqia Minya and Qena The main objectives of this campaign are to promote breast cancer awareness and the importance of early diagnosis screening for breast cancer and treatment of diagnosed cases according to recent protocols Suspected cases are referred for further investigation and treatment at no cost for the participants The media center for the Council of Ministers announced that 85 million women had been examined by October 20 2020 from all over Egypt with the aim of reaching 31 million women 18
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