The Association of MicroRNA21-155 Levels With Acute Side Effects In Patients With Stage III NSCLC With Definitive CRT

Sponsor

Ankara University (Other)

Overall Status

Completed

CT.gov ID

NCT06015815

Collaborator

(none)

Enrollment

Location

10.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present investigation constitutes a prospective cohort study. The objectives encompass the assessment of miRNA expression levels in total exosomes derived from peripheral circulation tissues of stage III definite KRT NSCLC patients both at the beginning and conclusion of their treatment. Furthermore, an exploration is conducted into the potential correlation existing between alterations in miRNA levels and the incidence of acute treatment-related side effects.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer Stage III

Detailed Description

Categorical variables were illustrated using both percentage distributions and numerical counts, while continuous variables were characterized using the mean accompanied by the standard deviation, and the median accompanied by the minimum and maximum values. The assessment of the normality of continuous variables encompassed a combination of visual methods such as histograms and probability plots, along with analytical tests like the Kolmogorov-Smirnov and Shapiro-Wilk tests.

In instances where data exhibited a normal distribution, Student's t-test was utilized for comparing two groups. For non-normally distributed data, the Mann-Whitney U test was applied. The comparison of categorical variables between independent groups involved Chi-square and Fisher's exact tests. Changes within dependent groups were evaluated using the Wilcoxon test. When performing pairwise comparisons among three or more groups, p-values were calculated while employing Bonferroni correction.

For the statistical analysis of the research data, the Statistical Package for Social Sciences (SPSS) version 25.0 for Windows (SPSS Inc. Chicago, USA) was utilized. The significance level was set at p<0.05. Additionally, it is important to note that p-values falling within the range of 0.1 to 0.05 were considered indicative of a statistical trend in this study.

Study Design

Study Type:

Observational

Actual Enrollment :

21 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Association of MicroRNA-21 And MicroRNA-155 Levels With Acute Side Effects In Patients With Stage III Non Small Lung Cancer With Definite Chemoradiotherapy

Actual Study Start Date :

Oct 5, 2019

Actual Primary Completion Date :

Apr 29, 2020

Actual Study Completion Date :

Aug 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
stage III non-small cell lung cancer A total of 21 patients with stage III NSCLC who received definitive CRT were prospectively evaluated. The expression levels of miRNA-21 and miRNA-155 in serum at the beginning and end of the treatment

Outcome Measures

Primary Outcome Measures

To determine the relationship of miRNA levels with acute side effects of chemoradiotherapy [The participants will be followed for an average of six months, including the period from the beginning of the treatment until three months after the completion of the treatment.]
miRNA Expression Measurement: Peripheral blood samples were collected from patients in pre-treatment and post-treatment periods to gauge miRNA expression. Samples were stored under suitable conditions. miRNA-21 and miRNA-155 expression levels were quantified through qRT-PCR. Livak formula-based fold change calculations identified expression shifts from treatment start to end. Acute Side Effects Assessment: Acute effects were evaluated as per Cooperative Group Common Toxicity Criteria Acute Side Effects (CTCAE) v5.0. Patients were assessed weekly during treatment and at 1 and 3 months post-treatment, comprehensively analyzing acute effects during treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Patient over 18 years old.
To be between 0-2 according to Eastern Cooperative Oncology Group (ECOG) performance status (PS).
Patient with pathological diagnosis of NSCLC.
Stage 3 Patient
Patient with a definitive chemoradiotherapy (CRT) treatment plan.