Breast DiseaseNCT06026176
Pattern of Clinical Presentation of Different Breast Disease in Surgical Opd at BPKIHS
An observational study of Breast Disease and Breast Neoplasms, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial summary
Research Title PATTERN OF CLINICAL PRESENTATION OF DIFFERENT BREAST DISEASE IN SURGICAL OPD AT BPKIHS Rationale: The Study will help us to know about pattern of presentation of different breast diseases Aims and Objectives: 1. To investigate the pattern of symptoms in patients with Breast diseases 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Disease, Breast Neoplasms, Breast Pain
- How many people
- 1,023 participants
- Where
- 1 siteNepal
- Study dates
- 1 Aug 2022to 1 Aug 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who presented to the surgical outpatient department (OPD) of a community-based tertiary care hospital in Nepal. These patients sought medical attention for various breast-related complaints over a one-year period. The population includes both male and female individuals.
Who may be able to join
- Patients presenting in Surgical OPD with Breast and related complaints
Who cannot join
- Those who deny consent for participation
Trial locations and contacts
1 site in 1 country.
About this study
Research Title PATTERN OF CLINICAL PRESENTATION OF DIFFERENT BREAST DISEASE IN SURGICAL OPD AT BPKIHS
Rationale: The Study will help us to know about pattern of presentation of different breast diseases
Read more
Aims and Objectives:
- To investigate the pattern of symptoms in patients with Breast diseases
- To assess the burden of different Breast diseases. Research Hypothesis (if relevant): N/A
- Material \& Methods:
- Whether study involves Human/animals or both : Human
- Population/ participants: Files of patients presenting in Surgical OPD with Breast related complaints
- Type of study design: : Descriptive Research Design
- Human study : Inclusion Criteria: Patients presenting in Surgical OPD with Breast and related complaints Exclusion Criteria: Those who deny consent for participation.
- Expected sample size : 823 Sample size calculation: Mentioned in methodology
- Control groups : N/A
- Probable duration of study: 365 days
- Setting: Outpatient Department
- Parameter/Variables to be applied/measured Independent Variables i. Socio-demographic characteristics such as age, gender, address. ii. Family History
Dependent Variables:
- Clinical symptoms associated with breast disease ii. Type of breast disease (benign or malignant)
Outcome measures:
Primary (main outcome): All dependent variables
(i) Rational for statistical methods to be employed : Retrospective Study Data will be entered in Microsoft Excel and converted it into SPSS for statistical analysis For descriptive studies, percentage, ratio, mean, SD, median will be calculated along with graphical and tabular presentations.
For inferential statistics, bivariate analysis will be done using χ2 test and independent t test to find out the significant differences between dependent and independent variables at 95% confidence interval and p-value significant at <0.05. Multivariate logistic regression will be done to adjust for confounding.
(ii) Ethical clearance : Ethical clearance will be obtained from Under Graduate Medical Research Protocol Review Board (UM-RPRB) of BPKIHS.
(iii) Permission to use copyright questionnaire/Pro forma: Not applicable
(j) Maintain the confidentiality of subject Confidentiality of the participants will be maintained. Whether available resources are adequate: Yes
- Other resources needed: No
- For Intervention trial: Not applicable A. Permission from Drug Controller of Nepal required/ Not required/Received/ Applied when_____ B. Safety measure C. Plan to withdraw
Read the detailed description
Pattern of clinical presentation of different breast disease in surgical opd at BPKIHS
INTRODUCTION
Breast is a dynamic gland that experiences physiological changes throughout a female's reproductive years. Adolescence, menarche, and menopause are notable periods during which significant changes occur in the breasts. Breast diseases are more prevalent in females and encompass a spectrum of benign, infectious, and malignant disorders. Benign breast diseases, constituting the majority of cases, encompass a range of lesions, including developmental abnormalities, inflammatory lesions, epithelial, and stromal proliferations, as well as various neoplasms.
Benign breast disease is the primary cause of breast problems, with up to 30% of women experiencing a benign breast disorder that requires treatment at some point in their lives. The most common symptoms associated with these disorders are pain, lumpiness, or the presence of a lump.
Breast cancer is most commonly observed in the Western world and is extremely rare before the age of 20 years. It is also rare in males. Breast cancer occurs more frequently in women with a family history of the disease. The typical presentation of breast cancer involves the presence of a hard lump, which may be associated with indrawing of the nipple or overlying skin.
A study conducted in Nepal revealed that benign breast conditions accounted for 61.7% of cases, while malignancy accounted for 15.3%.
Pain is one of the most common breast symptoms experienced by women. Breast pain is typically classified as cyclical mastalgia, noncyclical mastalgia, or extra mammary (non-breast) pain. Cyclic mastalgia is breast pain that follows a clear relationship to the menstrual cycle. Noncyclic mastalgia may be constant or intermittent and is not linked to the menstrual cycle; it often occurs after menopause. Extramammary pain arises from the chest wall or other sources but is interpreted as originating within the breast. The risk of cancer in a woman presenting with breast pain as her only symptom is extremely low.
Breast lump/mass is also one of the most common breast symptoms. The discovery of a breast mass, whether self-detected or identified by a clinician, is a common and often distressing occurrence for many women. Although most detected breast masses are benign, it is essential for every woman presenting with a breast mass to undergo evaluation to rule out or diagnose cancer.
Nipple discharge ranks as the third most common breast complaint, following breast pain and breast mass. It is usually a benign condition and can present in several forms, including milky, multicolored and sticky, purulent, clear and watery, yellow or serous, pink or serosanguinous, and bloody or sanguinous. The characteristics of the nipple discharge aid in the early diagnosis and management of breast disease. The most common cause of pathologic nipple discharge is a benign papilloma, followed by ductal ectasia, while carcinoma is the least likely cause.
Breast diseases represent a significant health concern worldwide, including Nepal. Despite this, there have been relatively few studies conducted in Nepal to investigate the spectrum of breast diseases, and the available studies have been limited by small sample sizes. The current study aims to address this knowledge gap by examining the demographic profile of breast-related diseases and the rate of malignancy in our specific setting. The findings of this study can provide valuable information for healthcare providers in Nepal to improve early detection and management of breast diseases. Furthermore, it can serve as a foundation for future research to better understand the burden and nature of breast diseases in our population. This study's contribution to the global knowledge of breast diseases is particularly valuable, especially in countries with limited resources and healthcare infrastructure. Ultimately, the study seeks to enhance health outcomes and improve the quality of life for individuals affected by breast diseases in Nepal.
In a study conducted in Olabisi Onabanjo University Teaching Hospital in Nigeria, breast lump was the commonest clinical feature of breast disease. Over 60% of these were benign. Breast pain was a statistically significant presentation in patients with malignant breast disease.
In a study carried out at Chaudhry Rehmat Ali Memorial Trust Teaching Hospital Township Lahore, the commonest presentation was lump breast alone and it accounted for 50 patients of 142(35%). The other common symptom was lumpiness (19%) and pain in breast (14%).
In a prospective study conducted in HBS Hospital Islamabad, which included total of 225 female patients, frequency of the disorders was as follows. Fibroadenoma breast presenting as lump breast was found in n=69(30.6%) followed by cyclical mastalgia(n=62 (27.5%), breast abscess n=27(12%), duct ectasia n=18(8%), carcinoma breast n=13(5.7%), sebaceous cyst breast n=9(4%), mastitis n=8(3%), cracked nipples n=8(3%), noncyclical mastalgia n=4(1.7%), galactorrhea n=3(0.8%), breast budding n=1(0.4%), phyllodes tumor n=1(0.4%), blood stained nipple discharge n=1(0.4%) and nipple eczema n=1(0.4%).
In a three years study done in Maheshwara Medical College and Hospital in India 117 patients (110 Female and 7 Male) were studied. The maximum number of patients presented clinically with a lump in the breast (31.81%) and the second symptom was a pain in the breast (27.37%). The common breast diseases were benign and malignant neoplasms. In the benign conditions, most common was fibroadenoma (69 patients 62.72%) in young females. In older age >40 years, the breast cancer was common. All the seven male patients with breast enlargement clinically, diagnosed as gynecomastia and histopathologically confirmed.
A prospective descriptive study conducted between January 2015 and May 2015 at Manipal Teaching Hospital, a tertiary level hospital situated in western region of Nepal where 160 patients presenting with benign breast diseases were studied. Majority were female (96%). The commonest presentation of benign breast diseases was pain (45%), followed by lump (26%). Fibroadenoma accounted for 46%. This study showed that among the benign breast diseases in females there were preponderance of mastalgia and fibroadenoma followed by fibrocystic diseases.
METHODS
The research utilized a Descriptive Research Design to investigate various study variables. The study focused on socio-demographic characteristics such as age, sex, and address, as well as breast symptoms like pain, lump, discharge, nipple retraction, and sub-areolar fistula. These factors served as outcome variables in the study. The research was conducted at B.P. Koirala Institute of Health Sciences (BPKIHS), and the study population consisted of patients who presented with breast and related complaints in the Surgical OPD. The sampling method included all patients who attended the surgical OPD with breast-related complaints, and data was collected using a semi-structured questionnaire through interviews. The sample size was justified based on literature review and prevalence study calculations. Inclusion criteria were patients who presented in the Surgical OPD with relevant complaints, while those who denied consent were excluded. The data collection involved a validated proforma with sections on sociodemographic profiles and contextual information related to presenting symptoms and family history. Consent was obtained, and English or Nepali questionnaires were used based on participant preference.
Data entry was done in Microsoft Excel and the investigators used SPSS v11.5 for statistical analysis. We used descriptive and inferential statistical methods for data analysis. Descriptive statistics were presented in percentage, ratio, mean, SD and median along with presentation in graphical form. Categorical variables were analyzed with the χ2 test or with Fisher's exact test if at least one cell had an expected count < 5. P value <0.05 was considered to be significant.
- Conditions
- Breast Disease, Breast Neoplasms, Breast Pain, Breast Fibroadenoma
- Medical subject headings
- Breast Diseases, Breast Neoplasms, Mastodynia, Fibroadenoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical symptoms associated with breast disease
Measured: One year
Type of breast disease (benign or malignant)
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Aug 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseaseStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,023 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sishir Poudel, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026176
- Sponsor's protocol ID
- IRC/2433/022
- Status last verified
- Sep 2023
- First submitted
- 18 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Clinical Presentation of Different Breast Disease in Surgical Opd at BPKIHS
- ClinicalTrials.gov ID
- NCT06026176
- Acronym / sponsor ID
- IRC/2433/022
- Conditions
- Breast Disease, Breast Neoplasms, Breast Pain, Breast Fibroadenoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,023 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 6 Sep 2023 (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.
Research Title PATTERN OF CLINICAL PRESENTATION OF DIFFERENT BREAST DISEASE IN SURGICAL OPD AT BPKIHS
Rationale: The Study will help us to know about pattern of presentation of different breast diseases
Aims and Objectives:
- To investigate the pattern of symptoms in patients with Breast diseases
- To assess the burden of different Breast diseases. Research Hypothesis (if relevant): N/A
- Material \& Methods:
- Whether study involves Human/animals or both : Human
- Population/ participants: Files of patients presenting in Surgical OPD with Breast related complaints
- Type of study design: : Descriptive Research Design
- Human study : Inclusion Criteria: Patients presenting in Surgical OPD with Breast and related complaints Exclusion Criteria: Those who deny consent for participation.
- Expected sample size : 823 Sample size calculation: Mentioned in methodology
- Control groups : N/A
- Probable duration of study: 365 days
- Setting: Outpatient Department
- Parameter/Variables to be applied/measured Independent Variables i. Socio-demographic characteristics such as age, gender, address. ii. Family History
Dependent Variables:
- Clinical symptoms associated with breast disease ii. Type of breast disease (benign or malignant)
Outcome measures:
Primary (main outcome): All dependent variables
(i) Rational for statistical methods to be employed : Retrospective Study Data will be entered in Microsoft Excel and converted it into SPSS for statistical analysis For descriptive studies, percentage, ratio, mean, SD, median will be calculated along with graphical and tabular presentations.
For inferential statistics, bivariate analysis will be done using χ2 test and independent t test to find out the significant differences between dependent and independent variables at 95% confidence interval and p-value significant at <0.05. Multivariate logistic regression will be done to adjust for confounding.
(ii) Ethical clearance : Ethical clearance will be obtained from Under Graduate Medical Research Protocol Review Board (UM-RPRB) of BPKIHS.
(iii) Permission to use copyright questionnaire/Pro forma: Not applicable
(j) Maintain the confidentiality of subject Confidentiality of the participants will be maintained. Whether available resources are adequate: Yes
- Other resources needed: No
- For Intervention trial: Not applicable A. Permission from Drug Controller of Nepal required/ Not required/Received/ Applied when_____ B. Safety measure C. Plan to withdraw
Detailed description
Pattern of clinical presentation of different breast disease in surgical opd at BPKIHS
INTRODUCTION
Breast is a dynamic gland that experiences physiological changes throughout a female's reproductive years. Adolescence, menarche, and menopause are notable periods during which significant changes occur in the breasts. Breast diseases are more prevalent in females and encompass a spectrum of benign, infectious, and malignant disorders. Benign breast diseases, constituting the majority of cases, encompass a range of lesions, including developmental abnormalities, inflammatory lesions, epithelial, and stromal proliferations, as well as various neoplasms.
Benign breast disease is the primary cause of breast problems, with up to 30% of women experiencing a benign breast disorder that requires treatment at some point in their lives. The most common symptoms associated with these disorders are pain, lumpiness, or the presence of a lump.
Breast cancer is most commonly observed in the Western world and is extremely rare before the age of 20 years. It is also rare in males. Breast cancer occurs more frequently in women with a family history of the disease. The typical presentation of breast cancer involves the presence of a hard lump, which may be associated with indrawing of the nipple or overlying skin.
A study conducted in Nepal revealed that benign breast conditions accounted for 61.7% of cases, while malignancy accounted for 15.3%.
Pain is one of the most common breast symptoms experienced by women. Breast pain is typically classified as cyclical mastalgia, noncyclical mastalgia, or extra mammary (non-breast) pain. Cyclic mastalgia is breast pain that follows a clear relationship to the menstrual cycle. Noncyclic mastalgia may be constant or intermittent and is not linked to the menstrual cycle; it often occurs after menopause. Extramammary pain arises from the chest wall or other sources but is interpreted as originating within the breast. The risk of cancer in a woman presenting with breast pain as her only symptom is extremely low.
Breast lump/mass is also one of the most common breast symptoms. The discovery of a breast mass, whether self-detected or identified by a clinician, is a common and often distressing occurrence for many women. Although most detected breast masses are benign, it is essential for every woman presenting with a breast mass to undergo evaluation to rule out or diagnose cancer.
Nipple discharge ranks as the third most common breast complaint, following breast pain and breast mass. It is usually a benign condition and can present in several forms, including milky, multicolored and sticky, purulent, clear and watery, yellow or serous, pink or serosanguinous, and bloody or sanguinous. The characteristics of the nipple discharge aid in the early diagnosis and management of breast disease. The most common cause of pathologic nipple discharge is a benign papilloma, followed by ductal ectasia, while carcinoma is the least likely cause.
Breast diseases represent a significant health concern worldwide, including Nepal. Despite this, there have been relatively few studies conducted in Nepal to investigate the spectrum of breast diseases, and the available studies have been limited by small sample sizes. The current study aims to address this knowledge gap by examining the demographic profile of breast-related diseases and the rate of malignancy in our specific setting. The findings of this study can provide valuable information for healthcare providers in Nepal to improve early detection and management of breast diseases. Furthermore, it can serve as a foundation for future research to better understand the burden and nature of breast diseases in our population. This study's contribution to the global knowledge of breast diseases is particularly valuable, especially in countries with limited resources and healthcare infrastructure. Ultimately, the study seeks to enhance health outcomes and improve the quality of life for individuals affected by breast diseases in Nepal.
In a study conducted in Olabisi Onabanjo University Teaching Hospital in Nigeria, breast lump was the commonest clinical feature of breast disease. Over 60% of these were benign. Breast pain was a statistically significant presentation in patients with malignant breast disease.
In a study carried out at Chaudhry Rehmat Ali Memorial Trust Teaching Hospital Township Lahore, the commonest presentation was lump breast alone and it accounted for 50 patients of 142(35%). The other common symptom was lumpiness (19%) and pain in breast (14%).
In a prospective study conducted in HBS Hospital Islamabad, which included total of 225 female patients, frequency of the disorders was as follows. Fibroadenoma breast presenting as lump breast was found in n=69(30.6%) followed by cyclical mastalgia(n=62 (27.5%), breast abscess n=27(12%), duct ectasia n=18(8%), carcinoma breast n=13(5.7%), sebaceous cyst breast n=9(4%), mastitis n=8(3%), cracked nipples n=8(3%), noncyclical mastalgia n=4(1.7%), galactorrhea n=3(0.8%), breast budding n=1(0.4%), phyllodes tumor n=1(0.4%), blood stained nipple discharge n=1(0.4%) and nipple eczema n=1(0.4%).
In a three years study done in Maheshwara Medical College and Hospital in India 117 patients (110 Female and 7 Male) were studied. The maximum number of patients presented clinically with a lump in the breast (31.81%) and the second symptom was a pain in the breast (27.37%). The common breast diseases were benign and malignant neoplasms. In the benign conditions, most common was fibroadenoma (69 patients 62.72%) in young females. In older age >40 years, the breast cancer was common. All the seven male patients with breast enlargement clinically, diagnosed as gynecomastia and histopathologically confirmed.
A prospective descriptive study conducted between January 2015 and May 2015 at Manipal Teaching Hospital, a tertiary level hospital situated in western region of Nepal where 160 patients presenting with benign breast diseases were studied. Majority were female (96%). The commonest presentation of benign breast diseases was pain (45%), followed by lump (26%). Fibroadenoma accounted for 46%. This study showed that among the benign breast diseases in females there were preponderance of mastalgia and fibroadenoma followed by fibrocystic diseases.
METHODS
The research utilized a Descriptive Research Design to investigate various study variables. The study focused on socio-demographic characteristics such as age, sex, and address, as well as breast symptoms like pain, lump, discharge, nipple retraction, and sub-areolar fistula. These factors served as outcome variables in the study. The research was conducted at B.P. Koirala Institute of Health Sciences (BPKIHS), and the study population consisted of patients who presented with breast and related complaints in the Surgical OPD. The sampling method included all patients who attended the surgical OPD with breast-related complaints, and data was collected using a semi-structured questionnaire through interviews. The sample size was justified based on literature review and prevalence study calculations. Inclusion criteria were patients who presented in the Surgical OPD with relevant complaints, while those who denied consent were excluded. The data collection involved a validated proforma with sections on sociodemographic profiles and contextual information related to presenting symptoms and family history. Consent was obtained, and English or Nepali questionnaires were used based on participant preference.
Data entry was done in Microsoft Excel and the investigators used SPSS v11.5 for statistical analysis. We used descriptive and inferential statistical methods for data analysis. Descriptive statistics were presented in percentage, ratio, mean, SD and median along with presentation in graphical form. Categorical variables were analyzed with the χ2 test or with Fisher's exact test if at least one cell had an expected count < 5. P value <0.05 was considered to be significant.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who presented to the surgical outpatient department (OPD) of a community-based tertiary care hospital in Nepal. These patients sought medical attention for various breast-related complaints over a one-year period. The population includes both male and female individuals.
Key inclusion criteria (1 listed)
- Patients presenting in Surgical OPD with Breast and related complaints
Key exclusion criteria (1 listed)
- Those who deny consent for participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical symptoms associated with breast disease
Time frame: One year
Type of breast disease (benign or malignant)
Time frame: One Year
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 6 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Breast Disease and Breast Neoplasms, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
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 6 Sep 2023. 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 Nepal. 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?
Clinical symptoms associated with breast disease (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2023.