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Serum Trace Elements and Their Associations with Breast Cancer Subgroups in Sudanese Breast Cancer Patients in Breast Cancer Center of Khartoum- Khartoum State –Sudan - SEP 2022

ETH-20260803-0168 تاريخ التقديم: Aug 03, 2026 / Submitted: Aug 03, 2026
قيمة الرسوم / Payment Amount
21,000.00 SDG
نوع البحث / Research Type
ماجستير / Master's
فترة الدراسة / Study Period
Sep 01, 2026 - Jan 01, 2027
Needs Revision
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-20260803-0168
رقم الطلب
Request Number
ETH-20260803-0168
تاريخ تقديم الطلب
Date of Submission
2026-08-03

القسم الأول: معلومات الباحث / Principal Investigator Information

1. الاسم الكامل للباحث الرئيسي
Principal Investigator Full Name
Tanzeel Altaib Ali Salih
2. الجهة التي ينتمي إليها
Affiliation Type
-
3. الوظيفة / اللقب العلمي
Job Title/Academic Degree
-
4. البريد الإلكتروني
Email Address
Tanzeel.altaib22@gmail.com
5. رقم الهاتف
Phone Number
0111822444
المشرف / Supervisor
الاسم الكامل / Full Name
Dr. AHMED MOHAMMED ELAMIN ABDALLA
البريد الإلكتروني / Email
MohammedBadi020@gmail.com
الوظيفة / اللقب العلمي / Job Title
Associate Professor of Biochemistry and Molecular Biology
رقم الهاتف / Phone
0909091400
القسم / المؤسسة / Department
College of Applied and Industrial Sciences

القسم الثاني: تفاصيل الدراسة البحثية / Research Study Details

7. عنوان الدراسة
Study Title
Serum Trace Elements and Their Associations with Breast Cancer Subgroups in Sudanese Breast Cancer Patients in Breast Cancer Center of Khartoum- Khartoum State –Sudan - SEP 2022
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 thesis proposal outlines a case-control study investigating the role of serum trace elements in female breast cancer patients in Sudan. Study Background Breast cancer is a leading cause of cancer-related deaths among women globally. While trace elements play essential roles in metabolic pathways, enzymatic catalysis, and oxidative stress defenses, their potential impact on tumor progression remains complex and inconsistent across global populations. Tumor cells require high levels of ATP and show accelerated metabolic activity, such as glycolysis and lipolysis, which rely on trace elements as catalytic cofactors. Despite previous research, localized, high-quality data regarding serum trace element profiles in Sudanese women with breast cancer remains limited. Study ObjectivesGeneral Objective: To investigate serum trace element levels and their potential associations with breast cancer subgroups in Sudanese patients receiving care at the Breast Cancer Center of Khartoum in September 2022. Specific Objectives:Measure serum levels of specific trace elements—specifically Zinc, Copper, and Magnesium ($\mu\text{g/L}$)—in breast cancer patients using Atomic Absorption Spectrophotometry. Evaluate relationships between these serum element levels and breast cancer. Assess major clinical and demographic risk factors associated with breast cancer in the study cohort. Anticipated Outcomes & MethodologyStudy Population: A case-control, hospital-based study involving 100 diagnosed female breast cancer patients (aged over 40) compared with 50 healthy female controls. Primary Outcomes: Quantitative measurement and statistical analysis (using SPSS version 26) comparing trace element concentration variations between healthy controls and breast cancer patients, alongside secondary blood biochemical parameters (blood glucose and lipid profiles) and structured risk factor questionnaires. Impact: The findings aim to elucidate whether altered serum concentrations of Zinc, Copper, or Magnesium could serve as useful biochemical markers, prognostic indicators, or diagnostic targets for breast cancer management in Sudan.

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
The proposal was ethically approved by the ethical committee of the University of Bahri. The consent will be taken from each patient, and the permission from the Northern State Ministry of the Health and general manager of the hospital will be obtained. Research proposes and objectives will be explained to participant in clear simple words. Participant has right to voluntary informed consent. Participant has right to withdraw at any time. Participant has right to benefit from the researcher skills and knowledge. Participant has right to no harm (privacy and confidentiality by using coded data sheet). Investigation results will be showed to the participant immediately. Remaining blood sample will not be reused for other study. Precautions during sample collection will be taken into a count to protect from Covid 19. The filled sheets will be burned after completion the study.
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:
5ml of blood samples will be collected using EDTA or citrate as an anticoagulant, and be mixed for 10-20 min, then it will centrifuged at the speed of 2000-3000 r.p.m. for 20 min.
13. الفوائد المحتملة للمشاركين أو المجتمع
Potential Benefits to Participants or Society
The findings aim to elucidate whether altered serum concentrations of Zinc, Copper, or Magnesium could serve as useful biochemical markers, prognostic indicators, or diagnostic targets for breast cancer management in Sudan.
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: non

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
Tanzeel Altaib Ali Salih
التوقيع / Signature
_______________________
التاريخ / Date
2026-08-03

معلومات الباحث / Researcher Information

T

Tanzeel Altaib Ali Salih

Tanzeel.altaib22@gmail.com

0111822444

University of Bahri

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

Al Mohamdisin - Omdorman - Kharotum - Sudan

معلومات الدراسة / Study Information

ماجستير / Master's

ماجستير - Master

21,000.00 SDG

This thesis proposal outlines a case-control study investigating the role of serum trace elements in female breast cancer patients in Sudan. Study Background Breast cancer is a leading cause of cancer-related deaths among women globally. While trace elements play essential roles in metabolic pathways, enzymatic catalysis, and oxidative stress defenses, their potential impact on tumor progression remains complex and inconsistent across global populations. Tumor cells require high levels of ATP and show accelerated metabolic activity, such as glycolysis and lipolysis, which rely on trace elements as catalytic cofactors. Despite previous research, localized, high-quality data regarding serum trace element profiles in Sudanese women with breast cancer remains limited. Study ObjectivesGeneral Objective: To investigate serum trace element levels and their potential associations with breast cancer subgroups in Sudanese patients receiving care at the Breast Cancer Center of Khartoum in September 2022. Specific Objectives:Measure serum levels of specific trace elements—specifically Zinc, Copper, and Magnesium ($\mu\text{g/L}$)—in breast cancer patients using Atomic Absorption Spectrophotometry. Evaluate relationships between these serum element levels and breast cancer. Assess major clinical and demographic risk factors associated with breast cancer in the study cohort. Anticipated Outcomes & MethodologyStudy Population: A case-control, hospital-based study involving 100 diagnosed female breast cancer patients (aged over 40) compared with 50 healthy female controls. Primary Outcomes: Quantitative measurement and statistical analysis (using SPSS version 26) comparing trace element concentration variations between healthy controls and breast cancer patients, alongside secondary blood biochemical parameters (blood glucose and lipid profiles) and structured risk factor questionnaires. Impact: The findings aim to elucidate whether altered serum concentrations of Zinc, Copper, or Magnesium could serve as useful biochemical markers, prognostic indicators, or diagnostic targets for breast cancer management in Sudan.

Sep 01, 2026 - Jan 01, 2027

Sep 01, 2026 - Nov 01, 2026

الاعتبارات الأخلاقية / Ethical Considerations

Written

مخاطر منخفضة - Low Risk

The proposal was ethically approved by the ethical committee of the University of Bahri. The consent will be taken from each patient, and the permission from the Northern State Ministry of the Health and general manager of the hospital will be obtained. Research proposes and objectives will be explained to participant in clear simple words. Participant has right to voluntary informed consent. Participant has right to withdraw at any time. Participant has right to benefit from the researcher skills and knowledge. Participant has right to no harm (privacy and confidentiality by using coded data sheet). Investigation results will be showed to the participant immediately. Remaining blood sample will not be reused for other study. Precautions during sample collection will be taken into a count to protect from Covid 19. The filled sheets will be burned after completion the study.

5ml of blood samples will be collected using EDTA or citrate as an anticoagulant, and be mixed for 10-20 min, then it will centrifuged at the speed of 2000-3000 r.p.m. for 20 min.

The findings aim to elucidate whether altered serum concentrations of Zinc, Copper, or Magnesium could serve as useful biochemical markers, prognostic indicators, or diagnostic targets for breast cancer management in Sudan.