Non Small Cell Lung CancerNCT05815407
Expressiona and Diagnostic Potential of miRNAs in NSCLC
An observational study of Non Small Cell Lung Cancer, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Its to explore the expression pattern, diagnostic and prognostic potentials of miRs (106b-5p, 601 and 760) in serum of NSCLC patients Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 30 Sep 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Case-control
Who may be able to join
- First time and recently diagnosed NSCLC patient
Who cannot join
- Recurrent NSCLC
- Start of chemotherapy, radiotherapy or surgical intervention
- Previous treatment
- Cancer history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Expression Profiling of Serum miRNAs (106b-5p, 601, and 760) in Non-small Cell Lung Cancer Patients
Its to explore the expression pattern, diagnostic and prognostic potentials of miRs (106b-5p, 601 and 760) in serum of NSCLC patients
Read the detailed description
A retrospective observational study on NSCLC patients, to determine the serum expression levels if some miRNAs in NSCLC patients and to find if having proper diagnostic and prognostic values in early disease detection, and/or staging.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- No intervention
- 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.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| NSCLC patients | Patients were diagnosed with NSCLC at any stage, then will be subdivided into Early stage, Lympho-node involvement stage and Distant metastatic stage Receives: Other: No intervention | |
| Control subjects | Appearantly healthy age-matched individuals Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the expression
Expression profiling of the selected miRNAs
Measured: By the end of the study (September 2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Sep 2018
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
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 CancerStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, Cairo
- Responsible party
- Principal investigator, Ahmed Elshafei, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815407
- Sponsor's protocol ID
- FOP AlAzharU
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Expression Profiling of Serum miRNAs (106b-5p, 601, and 760) in Non-small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT05815407
- Acronym / sponsor ID
- FOP AlAzharU
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute, Cairo
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 18 Apr 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.
Its to explore the expression pattern, diagnostic and prognostic potentials of miRs (106b-5p, 601 and 760) in serum of NSCLC patients
Detailed description
A retrospective observational study on NSCLC patients, to determine the serum expression levels if some miRNAs in NSCLC patients and to find if having proper diagnostic and prognostic values in early disease detection, and/or staging.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSCLC patients | – | Other: No interventionPatients were diagnosed with NSCLC at any stage, then will be subdivided into Early stage, Lympho-node involvement stage and Distant metastatic stage |
| Control subjects | – | Other: No interventionAppearantly healthy age-matched individuals |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Case-control
Key inclusion criteria (1 listed)
- First time and recently diagnosed NSCLC patient
Key exclusion criteria (4 listed)
- Recurrent NSCLC
- Start of chemotherapy, radiotherapy or surgical intervention
- Previous treatment
- Cancer history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Control subjects, NSCLC patients |
Primary outcome
Determination of the expression
Time frame: By the end of the study (September 2022)
Expression profiling of the selected miRNAs
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 18 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Al-Azhar University at 1 site in Egypt.
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 1 inclusion and 4 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 18 Apr 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 Egypt. 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?
Determination of the expression (time frame: By the end of the study (September 2022)). 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 18 Apr 2023.