دكتوراه / PhD

1.5. Objectives: 1.5.1. General Objectives: To determine the prevalence and characterize the expression of Human Epidermal Growth Factor Receptor 2 (HER2) among colorectal cancer patients in Sudan. 1.5.2. Specific Objectives: 1. To determine the prevalence of HER2 expression among colorectal cancer patients. 2. To classify HER2 expression patterns in colorectal cancer tissue samples using immunohistochemistry. 3. To describe the sociodemographic characteristics of colorectal cancer patients included in the study. 4. To assess the association between HER2 expression and clinicopathological variables, including tumor site, histological type, tumor grade, and stage. 5. To evaluate the relationship between HER2 expression and histopathological features of colorectal cancer. 2. Materials and Methods 2.1 Study Design, Patient Selection, and Tissue Specimens This study will be conducted as an analytical cross-sectional study. Archived formalin-fixed paraffin-embedded (FFPE) colorectal cancer tissue samples and corresponding patient clinical data will be analyzed to determine the prevalence and patterns of HER2 expression and to assess its association with clinicopathological characteristics. In patients who underwent surgical resection at a major clinical center in Sudan, and treated at Merowe Medical City. The study will include archived colorectal cancer cases diagnosed between 2024 and 2026 to ensure an adequate sample size. As an analytical cross-sectional study, all variables will be assessed at a single point in time per case.

2.7 Ethical Considerations This research will be conducted in strict accordance with the ethical principles outlined in the Declaration of Helsinki (as revised in 2013) and the International Ethical Guidelines for Biomedical Research Involving Human Subjects. Ethical Approval: Formal agreement to conduct this research will be sought from the Research Ethics Board (REB) at Merowe University of Technology and from the respective Research Ethics Board (REB) and Northern state ministry of health of all included histopathology laboratories and hospitals in Sudan that provide archived tissue specimens. Research procedures will commence only after all necessary ethical clearances are secured. Patient Confidentiality and Data Security: Patient confidentiality will be maintained throughout the study. All collected clinical and pathological data will be anonymized and coded immediately upon collection to protect patient identity. The key linking codes to patient information will be secured and accessible only to the principal investigator. FFPE tissue blocks will be handled and stored in compliance with local regulatory guidelines, ensuring patient privacy is protected at all stages. As a retrospective study utilizing archived tissues, the specific requirements for individual patient consent will be reviewed and justified based on the ethical guidelines established by the local RECs, with a focus on waiver of consent for de-identified data.

NON

Colorectal Cancer (CRC) remains a highly prevalent and lethal malignancy in Sudan and across Africa, often presenting in younger patient demographics [24, 27]. While global oncological guidelines, particularly for metastatic CRC (mCRC), increasingly incorporate HER2-targeted therapies as a crucial treatment option for the 3-5% of RAS and BRAF wild-type patients who exhibit HER2 amplification [2, 3, 11], there is a significant data deficit in the local context. The molecular landscape of CRC in Sudanese patients including the prevalence, characteristics, and clinical relevance of HER2 status remains largely undetermined, building upon limited retrospective findings in the region [27]. This critical lack of local epidemiological and molecular data means that eligible patients in Sudan who could benefit from these specific, life-extending precision medicine treatments are currently not being systematically identified or offered optimal therapeutic pathways, resulting in a critical gap between international standards of care and local practice.