Clinical trial · Observational
The Role of Interleukin-7 Serum Level as Biological Marker in Breast Cancer
The Role of Interleukin-7 Serum Level as Biological Marker in Breast Cancer: a Cross-sectional, Observational, and Analytical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study has been to explore whether there is any elevation of Interleukin-7 serum level in the early invasive breast cancer (EIBC) patients in comparison with healthy controls. In addition the correlation between the Interleukin-7 serum level and histopathological characteristics of the tumor, has been evaluated. We have hypothesized that Interleukin-7 serum level is elevated in the patients diagnosed with early invasive BC in comparison with healthy control group, and positively correlates with the tumor size, poor cell differentiation, lymphovascular and perineural invasion, negative hormone receptors' status, axillary lymph node metastasis, and the high Ki-67 proliferation index. In addition, no difference in the Interleukin-7 serum level exists between the patients recruited in Croatia and Kosovo, respectively. This cross-sectional, observational, and analytical study has included 213 consecutive patients with EIBC (113 from Croatia and 100 from Kosovo) and 62 healthy participants as the control group (30 from Croatia and 32 from Kosovo). Blood samples have been taken from patients confirmed with breast cancer (BC) by biopsy, prior to surgical intervention and other oncological treatments, as well as from healthy participants. Interleukin-7 serum level has been measured, using "Sandwich" ELISA Immunoenzyme test. In addition, after the surgical intervention, the histopathological specimen examinations and the immunohistochemistry have been performed and analyzed. The differences of the distribution of the numerical variables have been analyzed with Mann-Whitney U test and Kruskal-Wallis ANOVA test. Correlations have been tested with Pearson coefficients. P value \<0.05 has been accepted as statistically significant.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Invasive | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Interleukin-7
- timeFrame
- 7 days
- description
- The amount of Interleukin-7 in the blood of the patients is determined in units (pg/ml), and is done using "Sandwich" ELISA Immunoenzyme test, human Interleukin-7 antibody, and Platinum ELISA using research tools from eBioscience Inc., located in San Diego, CA USA.
Secondary outcomes (9)
- measure
- Tumor size
- timeFrame
- 2 months
- description
- The tumor size is determined by units (cm)
- measure
- Histological type of tumor
- timeFrame
- 2 months
- description
- The tumors are classified in these histological types: Invasive ductal carcinoma, invasive lobular carcinoma and others.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with invasive breast cancer, confirmed with biopsy * Operable and without distant metastases. Exclusion Criteria: * Patients with acute and/or chronic inflammatory diseases, rheumatoid disease and other malignancies occurring simultaneously * Patients receiving immune modulatory therapy * Patients previously treated by surgery, chemotherapy, radiotherapy, target therapy or endocrine therapy * Patients with dementia or any other psychological disorders unable to willingly participate in the study. Exclusion Criteria for the control group: * Breast tumors or any other confirmed malignancies * Any acute or chronic inflammatory disease * Receiving immune modulatory therapy
References
Publications (0)
Data not yet available