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The Role of Interleukin-7 Serum Level as Biological Marker in Breast Cancer

NCT05300412 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 275

Last updated 2022-03-29

No results posted yet for this study

Summary

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

  • Breast Cancer Invasive

Sponsors & Collaborators

  • University Clinical Centre of Kosova

    lead OTHER

Principal Investigators

  • Besim Sermaxhaj, MD · University Clinical Center Kosovo

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-05
Primary Completion
2019-09-10
Completion
2019-12-20

Countries

  • Kosovo

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05300412 on ClinicalTrials.gov