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Clinical Characteristics and Treatment Patterns of Breast Cancer Patients at Dongola Oncology Center, Northern Sudan 2026

ETH-20261021-0233 تاريخ التقديم: Oct 21, 2026 / Submitted: Oct 21, 2026
قيمة الرسوم / Payment Amount
6,000.00 SDG
نوع البحث / Research Type
بكالوريوس / Bachelor's
فترة الدراسة / Study Period
Sep 15, 2026 - Nov 30, 2026
Approved
السودان - الولاية الشمالية
وزارة الصحة
الادارة العامة للتخطيط والتنمية الصحية
إدارة البحوث
لجنة الموافقة الأخلاقية
طلب الموافقة الأخلاقية - Ethical Approval Request Form
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Ethical Approval Request Form
General Administration for Planning and Health Development
Research Department
Ethical Approval Committee
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رقم التسلسل
Serial Number
SER-20261021-0233
رقم الطلب
Request Number
ETH-20261021-0233
تاريخ تقديم الطلب
Date of Submission
2026-10-21

القسم الأول: معلومات الباحث / Principal Investigator Information

1. الاسم الكامل للباحث الرئيسي
Principal Investigator Full Name
Roaa Abdalazeim Abdalghani Ali
2. الجهة التي ينتمي إليها
Affiliation Type
جامعة / University: Dongola university - Faculty of medicine and health sciences
Dongola university - Faculty of medicine and health sciences
3. الوظيفة / اللقب العلمي
Job Title/Academic Degree
-
4. البريد الإلكتروني
Email Address
roaaabdalazeim@gmail.com
5. رقم الهاتف
Phone Number
0969945950
المشرف / Supervisor
الاسم الكامل / Full Name
Kamal Abdallah Ali Mohammed
البريد الإلكتروني / Email
Kamal84@uofd.edu.sd
الوظيفة / اللقب العلمي / Job Title
Associate Professor of pharmacology
رقم الهاتف / Phone
0123625425
القسم / المؤسسة / Department
Dongola university Faculty of medicine,pharmacology department

القسم الثاني: تفاصيل الدراسة البحثية / Research Study Details

7. عنوان الدراسة
Study Title
Clinical Characteristics and Treatment Patterns of Breast Cancer Patients at Dongola Oncology Center, Northern Sudan 2026
8. نوع البحث (يرجى التحديد)
Type of Research (Please select)
☐دكتوراه / PhD
☐ماجستير / Master's
☑بكالوريوس / Bachelor's
☐دبلوم عالي / Postgraduate Diploma
☐دبلوم وسيط / Intermediate Diploma
☐ورقة علمية / Research Paper
☐تقرير علمي / Scientific Report
☐أبحاث طبية / Medical Research
☐أخرى / Other
9. وصف مختصر للبحث
Brief Description of Research
This is a retrospective, record-based study at Dongola Oncology Center, Northern State, Sudan. It describes the clinical characteristics and treatment patterns of breast cancer patients. Breast cancer is the leading cancer among Sudanese women, and most studies come from Khartoum, Gezira and Eastern Sudan. Little is published about patients managed at Dongola Oncology Center. This study therefore reviews the medical records of all patients with a documented breast cancer diagnosis who attended or were registered at the center between January 2023 and September 2026. The diagnosis may have been made at the center or at another facility. It uses total (census) sampling, so no sample size calculation is needed, and data are collected between September and November 2026 with a pre-designed data-collection sheet. Duplicate records and records that do not show the patient attended the center are excluded. The study aims to: describe demographic characteristics (age, sex, residence, marital status); describe clinical and pathological features (symptoms, tumor size, lymph-node status, stage, histological type and grade, ER/PR/HER2 status); describe treatment patterns (surgery, chemotherapy, radiotherapy, hormonal and targeted therapy); determine the proportion of patients presenting at an advanced stage (III or IV) and the factors associated with it; assess how complete the medical records are. The findings should give center-specific evidence to guide care and improve documentation.

القسم الثالث: الجوانب الأخلاقية / Ethical Considerations

10. طريقة الحصول على الموافقة من المشاركين
Method of Obtaining Consent from Participants
☑مكتوبة / Written
☐شفهية / Verbal
☐غير مطبقة / Not Applicable
☐ضمنية / Implied
☐إعفاء / Waiver
يرجى إرفاق نموذج الموافقة / Please attach consent form
11. آلية الحفاظ على سرية المعلومات
Confidentiality Measures
No patient names, phone numbers, or other direct identifiers will be collected. Each record will be assigned a unique study code, and the data will be entered into the electronic form using this code only. Patient files will be reviewed within Dongola Oncology Center and will not be removed from the premises. Collected data will be stored on a password-protected device accessible only to the research team and the supervisor. The data will be used for research purposes only, and results will be reported in aggregate form so that no individual patient can be identified.
12. مدى المخاطر على المشاركين
Risk Level to Participants
☐لا توجد / None
☑طفيفة / Minor
☐متوسطة / Moderate
☐عالية / High
يرجى توضيح أي مخاطر محتملة وخطة التعامل معها / Please describe any potential risks and mitigation:
Potential Risks This is a retrospective, record-based study involving no direct contact with patients and no interventional procedures. Therefore, it poses minimal risk to participants. The potential risks are limited to: 1. Breach of Confidentiality: The primary risk is the potential loss of privacy. To mitigate this, all data will be anonymized upon collection. No names, phone numbers, or national ID numbers will be recorded. Each patient will be assigned a unique study code. Data will be stored in a password-protected database accessible only to the principal investigators. 2. Psychological Distress: Although there is no direct interaction, handling sensitive oncology data will be done with the utmost respect and confidentiality to preserve patient dignity. No physical, social, or economic risks are anticipated. The study will not affect the patients' current or future clinical care at the oncology center. The benefits of understanding breast cancer patterns in Northern Sudan outweigh this minimal risk.
13. الفوائد المحتملة للمشاركين أو المجتمع
Potential Benefits to Participants or Society
Potential Benefits of the Study Although this study offers no direct personal benefit to the participants, it is expected to provide significant scientific and public health benefits: 1. Improved Local Understanding: This will be among the first studies to document the clinical characteristics, stage at presentation, and histopathological patterns of breast cancer in Northern Sudan, where data is currently scarce. 2. Optimization of Patient Care: By analyzing current treatment patterns, the study will help identify gaps in management and guide the development of more effective, evidence-based local treatment protocols at Dongola Oncology Center. 3. Public Health Planning: The findings will provide valuable data for health authorities to improve early detection programs, resource allocation, and awareness campaigns tailored to the population of Northern State. 4. Contribution to Scientific Literature: The study will contribute to the national and regional cancer registry, supporting future research and comparison with other centers in Sudan and Africa. In summary, the study aims to enhance the quality of oncology services and ultimately improve outcomes for future breast cancer patients in the region.
14. هل تشمل الدراسة فئات ضعيفة؟
Does the study involve vulnerable groups?
☐الأطفال / Children
☐النساء الحوامل / Pregnant Women
☐اللاجئون/النازحون / Refugees/Displaced
☐ذوو الإعاقة / People with Disabilities
☐أخرى / Other:

القسم الرابع: قائمة المرفقات المطلوبة / Required Attachments

نسخة من المقترح البحثي الكامل
Full Research Proposal
أدوات جمع البيانات
Data Collection Tools
خطاب تسهيل من الجامعة
University Facilitation Letter

القسم الخامس: الإقرار والتوقيع / Acknowledgment and Signature

أُقر أنا الموقع أدناه بأن جميع المعلومات الواردة في هذه الاستمارة صحيحة وكاملة، وأتعهد بعدم البدء في أي جزء من الدراسة قبل الحصول على الموافقة الأخلاقية الرسمية، والالتزام بجميع الإرشادات والمعايير الأخلاقية المعتمدة من قبل لجنة الموافقة الأخلاقية.
I, the undersigned, acknowledge that all information provided in this form is accurate and complete, and I agree not to begin any part of the study before receiving official ethical approval, and to comply with all ethical guidelines and standards approved by the Ethical Approval Committee.
اسم الباحث الرئيسي / Principal Investigator Name
Roaa Abdalazeim Abdalghani Ali
التوقيع / Signature
_______________________
التاريخ / Date
2026-10-21

معلومات الباحث / Researcher Information

R

Roaa Abdalazeim Abdalghani Ali

roaaabdalazeim@gmail.com

0969945950

جامعة: Dongola university الكلية: Faculty of medicine and health sciences
S

Sitalbanat Mosnad Gadora Mosnad

Sitalbanatmosnad@gmail.com

0126314409

جامعة: Dongola university الكلية: Faculty of medicine and health sciences

Dongola Oncology Center

اسم المؤسسة التي سيتم فيها عمل البحث / Name of the institution where the research will be conducted

Dongola locality,Northern state

معلومات الدراسة / Study Information

بكالوريوس / Bachelor's

بكالوريوس - Bachelor

6,000.00 SDG

This is a retrospective, record-based study at Dongola Oncology Center, Northern State, Sudan. It describes the clinical characteristics and treatment patterns of breast cancer patients. Breast cancer is the leading cancer among Sudanese women, and most studies come from Khartoum, Gezira and Eastern Sudan. Little is published about patients managed at Dongola Oncology Center. This study therefore reviews the medical records of all patients with a documented breast cancer diagnosis who attended or were registered at the center between January 2023 and September 2026. The diagnosis may have been made at the center or at another facility. It uses total (census) sampling, so no sample size calculation is needed, and data are collected between September and November 2026 with a pre-designed data-collection sheet. Duplicate records and records that do not show the patient attended the center are excluded. The study aims to: describe demographic characteristics (age, sex, residence, marital status); describe clinical and pathological features (symptoms, tumor size, lymph-node status, stage, histological type and grade, ER/PR/HER2 status); describe treatment patterns (surgery, chemotherapy, radiotherapy, hormonal and targeted therapy); determine the proportion of patients presenting at an advanced stage (III or IV) and the factors associated with it; assess how complete the medical records are. The findings should give center-specific evidence to guide care and improve documentation.

Sep 15, 2026 - Nov 30, 2026

Oct 26, 2026 - Nov 10, 2026

الاعتبارات الأخلاقية / Ethical Considerations

Written

مخاطر منخفضة - Low Risk

No patient names, phone numbers, or other direct identifiers will be collected. Each record will be assigned a unique study code, and the data will be entered into the electronic form using this code only. Patient files will be reviewed within Dongola Oncology Center and will not be removed from the premises. Collected data will be stored on a password-protected device accessible only to the research team and the supervisor. The data will be used for research purposes only, and results will be reported in aggregate form so that no individual patient can be identified.

Potential Risks This is a retrospective, record-based study involving no direct contact with patients and no interventional procedures. Therefore, it poses minimal risk to participants. The potential risks are limited to: 1. Breach of Confidentiality: The primary risk is the potential loss of privacy. To mitigate this, all data will be anonymized upon collection. No names, phone numbers, or national ID numbers will be recorded. Each patient will be assigned a unique study code. Data will be stored in a password-protected database accessible only to the principal investigators. 2. Psychological Distress: Although there is no direct interaction, handling sensitive oncology data will be done with the utmost respect and confidentiality to preserve patient dignity. No physical, social, or economic risks are anticipated. The study will not affect the patients' current or future clinical care at the oncology center. The benefits of understanding breast cancer patterns in Northern Sudan outweigh this minimal risk.

Potential Benefits of the Study Although this study offers no direct personal benefit to the participants, it is expected to provide significant scientific and public health benefits: 1. Improved Local Understanding: This will be among the first studies to document the clinical characteristics, stage at presentation, and histopathological patterns of breast cancer in Northern Sudan, where data is currently scarce. 2. Optimization of Patient Care: By analyzing current treatment patterns, the study will help identify gaps in management and guide the development of more effective, evidence-based local treatment protocols at Dongola Oncology Center. 3. Public Health Planning: The findings will provide valuable data for health authorities to improve early detection programs, resource allocation, and awareness campaigns tailored to the population of Northern State. 4. Contribution to Scientific Literature: The study will contribute to the national and regional cancer registry, supporting future research and comparison with other centers in Sudan and Africa. In summary, the study aims to enhance the quality of oncology services and ultimately improve outcomes for future breast cancer patients in the region.