Evaluation of Serum IL-7 as a Biomarker in Breast Cancer

NCT ID: NCT07133685

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-12-01

Brief Summary

Breast cancer is one of the most commonly diagnosed cancers and leading cause of cancer-related mortality in women worldwide, posing a serious threat to their health (1).

It is a heterogeneous disease, characterized by varying molecular subtypes such as hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2-positive), and triple-negative breast cancer (TNBC) (2).

Breast cancer develops as a result of several internal and external factors (3-5). Poor lifestyle choices, environmental factors, and social-psychological factors are all linked to its occurrence. It has been demonstrated that 5% to 10% of breast cancers can be attributed to genetic mutations and family history, while 20% to 30% of breast cancers can be attributed to factors that may be modifiable (6). An early and accurate diagnosis is essential for effective treatment and improved patient survival.

The human immune system plays a fundamental role in the defense against malignant diseases by recognizing and eliminating cancerous cells at the early stages of tumor development. Many research has been conducted on various cytokines to assess their role in the development of various tumors.

IL-7 is an essential cytokine for the adaptive immune system, which is crucial for the development of B cells, the proliferation and survival of memory T cells and naive T cells, as well as the development of thymic T cells (7).

IL-7 action is realized through two main signaling pathways: (Jak-Stat and PI3K-Akt) (8). Through these pathways, it has an impact on the development, survival, proliferation, differentiation and maturity of immune cells such as T-lymphocytes, B-lymphocytes, and natural killer cells (9).

IL-7 has strong immunomodulatory act on tumor cells and exerts anti-tumor effects by enhancing tumor eradication or adoptive immunity (10).

However, IL-7 may also facilitate tumor progression by activating the same downstream AKT pathways .

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

study group

Female patients diagnosed with Breast cancer based on pathological and radiological confirmation.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Female patients diagnosed with Breast cancer based on pathological and radiological confirmation.
• Age > 18

Exclusion Criteria

• Male
• Patients diagnosed with other malignant diseases

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Aya Emad Eldin Abd Allah Mahran

residant doctor at Assiut university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Serum IL-7 Breast Cancer

Identifier Type: -

Identifier Source: org_study_id