Surgical Management of Multiple Mucoepidermoid Carcinoma... | NCT03988959

Studies
Surgical Management of Multiple Mucoepidermoid Carcinoma and Adenocarcinoma

NCT03988959

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jun 18, 2019Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Adenocarcinoma; Mucoepidermoid Carcinoma

Interventions

resection of mucoeidermoid carcinoma

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jun 1, 2019Actual

Completion Date

Jun 1, 2019Actual

First Submitted Date

Jun 13, 2019

First Submission Date that Met QC Criteria

Jun 14, 2019

First Posted Date

Jun 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2019

Last Update Posted Date

Jun 18, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Heba Sleem, professour doctor and principle investigator in department of oral and maxillofacial surgery, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Other	Standard resection	Procedure: resection of mucoeidermoid carcinoma

Interventions

Name	Type	Description	Arm Group Labels	Other Names
resection of mucoeidermoid carcinoma	Procedure	Surgical resection parotid with preservation of facial nerve	Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients suffering from salivary gland tumor

Exclusion Criteria:

healthy patients with no tumors

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohamed Diaa, Prof Dr	Dean of Faculty	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain shams university		Cairo		11757	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to share those data currently with other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000230	Adenocarcinoma
D018277	Carcinoma, Mucoepidermoid
D012468	Salivary Gland Neoplasms

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided