Adenocarcinoma; Mucoepidermoid CarcinomaNCT03988959
Surgical Management of Multiple Mucoepidermoid Carcinoma and Adenocarcinoma
A study testing resection of mucoeidermoid carcinoma in people with Adenocarcinoma; Mucoepidermoid Carcinoma, run by Ain Shams University at 1 site in Egypt.
Trial summary
A case series of patient having mucoepidermoid carcinoma, had standard treatment protocol and surgeries and followup was performed and the patient postoperative quality of life and recurrent rate was recorded Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Adenocarcinoma; Mucoepidermoid Carcinoma
- What is being tested?
- resection of mucoeidermoid carcinoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Jun 2019
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients suffering from salivary gland tumor
Who cannot join
- healthy patients with no tumors
Trial locations and contacts
1 site in 1 country.
About this study
A case series of patient having mucoepidermoid carcinoma, had standard treatment protocol and surgeries and followup was performed and the patient postoperative quality of life and recurrent rate was recorded
Read the detailed description
This case series presents mucoepidermoid carcinoma. Palatal mass was resected with safety margin then immediate opturator inserted; superficial parotidectomy was also done for parotid lesion sparing facial nerve. Post-operative radiotherapy was recommended by pathologist due to evident perineural spread. The patient is tumor free after one year follow-up.
Clinical reports about synchronous multiple salivary tumors are very rare, consequently there is little known about its management and clinical presentation. Presence of one or more risk factor should favor expectation of multiple tumors and mandate examination of all salivary tissues. Each tumor should be diagnosed and treated separately according to its nature and extension.
- Conditions
- Adenocarcinoma; Mucoepidermoid Carcinoma
- Being tested
- resection of mucoeidermoid carcinoma
- Keywords
- salivary gland tumor
- Medical subject headings
- Adenocarcinoma, Carcinoma, Mucoepidermoid, Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resection of mucoeidermoid carcinomaProcedure or surgery
Also called Conservative superficial partoidectomy
Surgical resection parotid with preservation of facial nerve
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Standard resection Receives: Procedure: resection of mucoeidermoid carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
in grades the quality of life of patients is assessed by visual analogue scale in a scale from 1-10. higher values indicates better quality of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Jan 2019
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma; Mucoepidermoid CarcinomaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a case series was performed on 7 patients having mucoepidermoid carcinoma
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Sleem, Ain Shams University
- Investigators
- Mohamed Diaa, Prof Dr, Study director, Dean of Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988959
- Sponsor's protocol ID
- 110/2/2018
- Status last verified
- Jun 2019
- First submitted
- 13 Jun 2019
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share those data currently with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Management of Multiple Mucoepidermoid Carcinoma and Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03988959
- Acronym / sponsor ID
- 110/2/2018
- Conditions
- Adenocarcinoma; Mucoepidermoid Carcinoma
- Keywords
- salivary gland tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 18 Jun 2019 (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.
A case series of patient having mucoepidermoid carcinoma, had standard treatment protocol and surgeries and followup was performed and the patient postoperative quality of life and recurrent rate was recorded
Detailed description
This case series presents mucoepidermoid carcinoma. Palatal mass was resected with safety margin then immediate opturator inserted; superficial parotidectomy was also done for parotid lesion sparing facial nerve. Post-operative radiotherapy was recommended by pathologist due to evident perineural spread. The patient is tumor free after one year follow-up.
Clinical reports about synchronous multiple salivary tumors are very rare, consequently there is little known about its management and clinical presentation. Presence of one or more risk factor should favor expectation of multiple tumors and mandate examination of all salivary tissues. Each tumor should be diagnosed and treated separately according to its nature and extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a case series was performed on 7 patients having mucoepidermoid carcinoma
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Procedure: resection of mucoeidermoid carcinomaStandard resection |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients suffering from salivary gland tumor
Key exclusion criteria (1 listed)
- healthy patients with no tumors
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 |
|---|---|---|
| resection of mucoeidermoid carcinomaAlso: Conservative superficial partoidectomySurgical resection parotid with preservation of facial nerve | Procedure or surgery | Control |
Primary outcome
Quality of life
Time frame: 6 months
in grades the quality of life of patients is assessed by visual analogue scale in a scale from 1-10. higher values indicates better quality of life
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 Jun 2019.
- Individual participant dataSharing planned: No. No plan to share those data currently with other researchers
Related trials for Adenocarcinoma; Mucoepidermoid Carcinoma
Active, not recruitingPhase 2
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors That Have Been Removed By Surgery
Head and Neck Cancer
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.
Mohamed Diaa, Prof Dr study director
Dean of Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resection of mucoeidermoid carcinoma in people with Adenocarcinoma; Mucoepidermoid Carcinoma, run by Ain Shams 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 18 Jun 2019. 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?
Quality of life (time frame: 6 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 18 Jun 2019.