Malignant Neoplasm of Salivary GlandNCT03687294
Diagnostic Accuracy of Human Transcriptional Activator(MYB) Expression by ELISA Technique Versus Immmunohistochemistry in Detecting Salivary Gland Carcinomas
An observational study of Malignant Neoplasm of Salivary Gland and Benign Neoplasm of Salivary Gland, run by Cairo University at 1 site in Egypt.
Trial summary
in this resarch we will use ELISA Technique to estimate Human Transcriptional Activator(MYB) Expression .compare it by Immmunohistochemistry analysis of MYB Expression in the malignant and benign salivary gland tumor Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Neoplasm of Salivary Gland, Benign Neoplasm of Salivary Gland
- What is being tested?
- enzyme linked immunosorbent assay (ELISA)
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2019to Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Egyptian population
Who may be able to join
- Patients with clinically evident salivary gland tumors; malignant tumors will be recruited in group I
- Benign tumors will be recruited in group II.
Who cannot join
- Subjects taking any drugs inducing any changes that could affect the salivary glands.
- Pregnant females.
- Subjects having any allergies, infectious or autoimmune diseases.
- Subjects having any metabolic disorders that can be manifested with salivary gland swelling as diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute
Cairo, 11796
0223689711, webmaster@nci.cu.edu.eg
About this study
in this resarch we will use ELISA Technique to estimate Human Transcriptional Activator(MYB) Expression .compare it by Immmunohistochemistry analysis of MYB Expression in the malignant and benign salivary gland tumor
- Being tested
- enzyme linked immunosorbent assay (ELISA)
- Medical subject headings
- Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enzyme linked immunosorbent assay (ELISA)Device
ELISA measure MYB in tissue biopsy in benign and malignant salivary gland tumors
| Study group | Role | What they receive |
|---|---|---|
| Group I | patients suffering from malignant salivary gland tumors. Receives: Device: enzyme linked immunosorbent assay (ELISA) | |
| Group II | patients suffering from benign salivary gland tumors. Receives: Device: enzyme linked immunosorbent assay (ELISA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Human Transcriptional Activator(MYB) Expression by ELISA Technique Versus Immmunohistochemistry in Detecting Salivary Gland Carcinomas
Diagnostic Accuracy of Human Transcriptional Activator(MYB) Expression by ELISA Technique Versus Immmunohistochemistry in Detecting Salivary Gland Carcinomas.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start12 Jan 2019
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of Salivary GlandStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousra Refaey, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687294
- Sponsor's protocol ID
- yousrarefaey11
- Status last verified
- Jul 2020
- First submitted
- 26 Sep 2018
- Last updated
- 21 Jul 2020
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Human Transcriptional Activator(MYB) Expression by ELISA Technique Versus Immmunohistochemistry in Detecting Salivary Gland Carcinomas
- ClinicalTrials.gov ID
- NCT03687294
- Acronym / sponsor ID
- yousrarefaey11
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Jan 2019 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 27 Sep 2018 (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.
in this resarch we will use ELISA Technique to estimate Human Transcriptional Activator(MYB) Expression .compare it by Immmunohistochemistry analysis of MYB Expression in the malignant and benign salivary gland tumor
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Device: enzyme linked immunosorbent assay (ELISA)patients suffering from malignant salivary gland tumors. |
| Group II | – | Device: enzyme linked immunosorbent assay (ELISA)patients suffering from benign salivary gland tumors. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Egyptian population
Key inclusion criteria (2 listed)
- Patients with clinically evident salivary gland tumors; malignant tumors will be recruited in group I
- Benign tumors will be recruited in group II.
Key exclusion criteria (4 listed)
- Subjects taking any drugs inducing any changes that could affect the salivary glands.
- Pregnant females.
- Subjects having any allergies, infectious or autoimmune diseases.
- Subjects having any metabolic disorders that can be manifested with salivary gland swelling as diabetes mellitus.
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 |
|---|---|---|
| enzyme linked immunosorbent assay (ELISA)ELISA measure MYB in tissue biopsy in benign and malignant salivary gland tumors | Device | Group I, Group II |
Primary outcome
Diagnostic Accuracy of Human Transcriptional Activator(MYB) Expression by ELISA Technique Versus Immmunohistochemistry in Detecting Salivary Gland Carcinomas
Time frame: two years
Diagnostic Accuracy of Human Transcriptional Activator(MYB) Expression by ELISA Technique Versus Immmunohistochemistry in Detecting Salivary Gland Carcinomas.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: No
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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.
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 Malignant Neoplasm of Salivary Gland and Benign Neoplasm of Salivary Gland, run by Cairo 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 2 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: status not confirmed, as of the sponsor's last update on 21 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yousra refaey (01014458092, yousrarefaey@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Human Transcriptional Activator(MYB) Expression by ELISA Technique Versus Immmunohistochemistry in Detecting Salivary Gland Carcinomas (time frame: two years). 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 21 Jul 2020.