NCT07133685

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 .

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Sep 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Sep 2025Dec 2026

First Submitted

Initial submission to the registry

August 14, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 14, 2025

Last Update Submit

August 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • concentration of the serum level of IL-7 in patients with breast cancer

    concentration of the serum level of IL-7 in patients with breast cancer

    baseline

Study Arms (1)

study group

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

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Male
  • Patients diagnosed with other malignant diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
residant doctor at Assiut university hospital

Study Record Dates

First Submitted

August 14, 2025

First Posted

August 21, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 21, 2025

Record last verified: 2025-08