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

NCT06015815 | Completed

• 1 other identifier: SRC Project No: 19L0230007
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer Stage III

Keywords

Non-Small Cell Lung Cancer; Radiotherapy; MicroRNA-21; MicroRNA-155; Acute Side Effect

Outcome Measures

Primary Outcomes (1)

• To determine the relationship of miRNA levels with acute side effects of chemoradiotherapy

  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.

  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.

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligibility criteria for inclusion in the study were defined as follows: patients aged 18 years or older who are histologically diagnosed with NSCLC and are in stage 3 according to the 8th edition of the American Cancer Committee (AJCC) staging system and are scheduled to receive treatment. During the staging of the patients, all of them underwent thorax computer tomography, positron emissions tomography (PET), and endobronchial ultrasound (EBUS) biopsy and cranial magnetic resonance imaging (MRI).

You may qualify if:

• 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.

You may not qualify if:

• Patient with second primary malignancy.
• History of previous radiotherapy to the thoracic region
• Patient with advanced cardiovascular disease.
• Patient with neurological or physical deficit.
• Patient with autoimmune disease

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Medicine School Radiation Oncology

Ankara, 06590, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

miRNA-21 and miRNA 155 in exosomes were examined in material from peripheral blood.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Esra Gümüştepe, M.D

  Ankara University

  PRINCIPAL INVESTIGATOR

• Serap Akyürek, M.D

  Ankara University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor research assistant

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 29, 2023
• Study Start: October 5, 2019
• Primary Completion: April 29, 2020
• Study Completion: August 15, 2020
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)