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

NCT05300412 | Completed

• 1 other identifier: grid.412416.4
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Breast cancer, interleukins, interleukin-7, biomarker

Outcome Measures

Primary Outcomes (1)

• Interleukin-7

  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.

  7 days

Secondary Outcomes (9)

• Tumor size

  2 months

• Histological type of tumor

  2 months

• Histological grade

  2 months

• Lymphovascular and perineural invasion

  2 months

• Metastatic lymph nodes

  2 months

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In order to determine the Interleukin-7 serum level, blood samples (10 ml venous blood) have been taken from 213 EIBC patients, from which 100 from Kosovo University Hospital and 113 from Croatian University Hospital, prior to surgery and other oncological treatments, such as chemotherapy, radiotherapy, endocrine therapy or target therapy. On the other hand, the blood samples (10 ml venous blood) have been taken also from other 62 healthy participants, which compose the control group, from whom 32 from Kosovo and the other 30 from Croatia. Blood samples categorized in tubes have been identifiable only by the numbers attributed to participants, and have been stored frozen in temperatures of -20˚C, in order to conduct the analysis later. Patients have been selected as consecutive among women, aged between 20 - 70. Also, the control group has been composed by women, aged between 20 - 70.

You may qualify if:

• Patients with invasive breast cancer, confirmed with biopsy
• Operable and without distant metastases.

You may not qualify if:

• 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.
• Breast tumors or any other confirmed malignancies
• Any acute or chronic inflammatory disease
• Receiving immune modulatory therapy

Sponsors & Collaborators

• University Clinical Centre of Kosova: lead

Study Sites (1)

Faton I. Sermaxhaj, MD

Pristina, 10000, Kosovo

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Besim Sermaxhaj, MD

  University Clinical Center Kosovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 29, 2022
• Study Start: June 5, 2018
• Primary Completion: September 10, 2019
• Study Completion: December 20, 2019
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

KO (1)