Non-small Cell Lung Cancer Stage IIINCT06015815
The Association of MicroRNA21-155 Levels With Acute Side Effects In Patients With Stage III NSCLC With Definitive CRT
An observational study of Non-small Cell Lung Cancer Stage III, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-small Cell Lung Cancer Stage III
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2019to 15 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Medicine School Radiation Oncology
Ankara, 06590
About this study
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
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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer Stage III
- Keywords
- Non-Small Cell Lung Cancer, Radiotherapy, MicroRNA-21, MicroRNA-155, Acute Side Effect
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start5 Oct 2019
- Primary completion29 Apr 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage IIIStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Gümüştepe, Ankara University
- Investigators
- Esra Gümüştepe, M.D, Principal investigator, Ankara UniversitySerap Akyürek, M.D, Study director, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015815
- Sponsor's protocol ID
- SRC Project No: 19L0230007
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06015815
- Acronym / sponsor ID
- SRC Project No: 19L0230007
- Conditions
- Non-small Cell Lung Cancer Stage III
- Keywords
- Non-Small Cell Lung Cancer, Radiotherapy, MicroRNA-21, MicroRNA-155, Acute Side Effect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 5 Oct 2019 (actual)
- Primary completion
- 29 Apr 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the relationship of miRNA levels with acute side effects of chemoradiotherapy
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Non-small Cell Lung Cancer Stage III
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 3
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8
RecruitingPhase 3
A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.
Non Small Cell Lung Cancer
Not yet recruiting
Moderately Hypofractionated Versus Conventional Chemoradiotherapy With Consolidation Immunotherapy in Patients With Unresectable, Non-Targetable Stage III Non Small Cell Lung Cancer (NSCLC)
Stage III NSCLC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Gümüştepe, M.D principal investigator
Ankara University
Serap Akyürek, M.D study director
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer Stage III, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the relationship of miRNA levels with acute side effects of chemoradiotherapy (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.