Oral Squamous Cell CarcinomaNCT05708209
The Long Non Coding MALAT1 as a Potential Salivary Diagnostic Biomarker in Oral Squamous Cell Carcinoma Through Targeting mi RNA 124
An observational study of Oral Squamous Cell Carcinoma, run by Fayoum University at 1 site in Egypt.
Trial summary
Objective: is to determine the diagnostic accuracy of lncRNA MALAT1 as a potential salivary biomarker of OSCC as well as assessment of the salivary expression level of miRNA 124 which is targeted by MALAT1. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Jan 2023
- 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 20 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients with diagnosis of oral squamous cell carcinoma
Who may be able to join
- The study included patients with OSCC and healthy controls of both sexes.
Who cannot join
- Patients having systemic diseases such as; liver diseases, cardiovascular disease, nervous system, pulmonary, renal, endocrine, gastrointestinal disorders, or other types of cancer were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Objective: is to determine the diagnostic accuracy of lncRNA MALAT1 as a potential salivary biomarker of OSCC as well as assessment of the salivary expression level of miRNA 124 which is targeted by MALAT1. Materials and Methods: Saliva Samples were collected for the quantitative determination of salivary "MALAT1 and mi RNA -124" using quantitative Real-time Polymerase Chain Reaction technique for the two study groups, Group A: 20 patients with a diagnosis suggestive of OSCC and Group B: 20 age-and-sex-matched healthy individuals, as normal controls.
Read the detailed description
Materials and Methods: Saliva Samples were collected for the quantitative determination of salivary "MALAT1 and mi RNA -124" using quantitative Real-time Polymerase Chain Reaction technique for the two study groups, Group A: 20 patients with a diagnosis suggestive of OSCC and Group B: 20 age-and-sex-matched healthy individuals, as normal controls.
- Conditions
- Oral Squamous Cell Carcinoma
- Keywords
- Long non coding RNA, Oral squamous cell carcinoma, Micro RNA, Salivary biomarkers, MALAT1, Oral cancer biomarkers
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
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 |
|---|---|---|
| Group A | 20 patients with a diagnosis suggestive of OSCC | |
| Group B | 20 age-and-sex-matched healthy individuals, as normal controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantitative determination of salivary non-coding RNAs "MALAT1
quantitative determination of salivary non-coding RNAs "MALAT1 using quantitative Real-time Polymerase Chain Reaction technique (qRT-PCR) in the whole unstimulated saliva
Measured: 2 months
Secondary outcomes (1)
quantitative determination of salivary mi RNA -124"
quantitative determination of salivary mi RNA -124" using quantitative Real-time Polymerase Chain Reaction technique (qRT-PCR) in the whole unstimulated saliva
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Nov 2022
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Hassan Shalby, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708209
- Sponsor's protocol ID
- 19038219038211012
- Status last verified
- Sep 2023
- First submitted
- 22 Jan 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long Non Coding MALAT1 as a Potential Salivary Diagnostic Biomarker in Oral Squamous Cell Carcinoma Through Targeting mi RNA 124
- ClinicalTrials.gov ID
- NCT05708209
- Acronym / sponsor ID
- 19038219038211012
- Conditions
- Oral Squamous Cell Carcinoma
- Keywords
- Long non coding RNA, Oral squamous cell carcinoma, Micro RNA, Salivary biomarkers, MALAT1, Oral cancer biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 1 Feb 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.
Objective: is to determine the diagnostic accuracy of lncRNA MALAT1 as a potential salivary biomarker of OSCC as well as assessment of the salivary expression level of miRNA 124 which is targeted by MALAT1. Materials and Methods: Saliva Samples were collected for the quantitative determination of salivary "MALAT1 and mi RNA -124" using quantitative Real-time Polymerase Chain Reaction technique for the two study groups, Group A: 20 patients with a diagnosis suggestive of OSCC and Group B: 20 age-and-sex-matched healthy individuals, as normal controls.
Detailed description
Materials and Methods: Saliva Samples were collected for the quantitative determination of salivary "MALAT1 and mi RNA -124" using quantitative Real-time Polymerase Chain Reaction technique for the two study groups, Group A: 20 patients with a diagnosis suggestive of OSCC and Group B: 20 age-and-sex-matched healthy individuals, as normal controls.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –20 patients with a diagnosis suggestive of OSCC |
| Group B | – | –20 age-and-sex-matched healthy individuals, as normal controls. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of oral squamous cell carcinoma
Key inclusion criteria (1 listed)
- The study included patients with OSCC and healthy controls of both sexes.
Key exclusion criteria (1 listed)
- Patients having systemic diseases such as; liver diseases, cardiovascular disease, nervous system, pulmonary, renal, endocrine, gastrointestinal disorders, or other types of cancer were excluded.
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
quantitative determination of salivary non-coding RNAs "MALAT1
Time frame: 2 months
quantitative determination of salivary non-coding RNAs "MALAT1 using quantitative Real-time Polymerase Chain Reaction technique (qRT-PCR) in the whole unstimulated saliva
1 secondary outcome
quantitative determination of salivary mi RNA -124"
Time frame: 2 months
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 13 Sep 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 Oral Squamous Cell Carcinoma, run by Fayoum 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 1 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 13 Sep 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?
quantitative determination of salivary non-coding RNAs "MALAT1 (time frame: 2 months). 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 13 Sep 2023.