NCT03746730

Brief Summary

To evaluate the role of gray scale and Doppler ultrasound in characterizing of parotid and submandibular gland lesions in comparison to biopsy if needed

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

1.8 years

First QC Date

September 30, 2018

Last Update Submit

November 16, 2018

Conditions

Salivary Gland Diseases

Outcome Measures

Primary Outcomes (1)

  • the role of gray scale and Doppler ultrasound in characterizing of parotid and submandibular gland diseases in comparison to biopsy if needed

    the role of gray scale and Doppler ultrasound in characterizing of parotid and submandibular gland diseases in comparison to biopsy if needed

    baseline

Interventions

ultrasoundDEVICE

gray scale and doppler ultrasound

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in different age and sex groups with neck swelling, pain or any complaint related to parotid and submandibular gland detected by clinical examination.

You may qualify if:

  • \- Patients in different age and sex groups with neck swelling, pain or any complaint related to major salivary gland detected by clinical examination.

You may not qualify if:

  • patients who refused to sign a consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Zhang W, Zuo Z, Luo N, Liu L, Jin G, Liu J, Su D. Non-enhanced MRI in combination with color Doppler flow imaging for improving diagnostic accuracy of parotid gland lesions. Eur Arch Otorhinolaryngol. 2018 Apr;275(4):987-995. doi: 10.1007/s00405-018-4895-6. Epub 2018 Feb 12.

    PMID: 29430614BACKGROUND

  • Rzepakowska A, Osuch-Wojcikiewicz E, Sobol M, Cruz R, Sielska-Badurek E, Niemczyk K. The differential diagnosis of parotid gland tumors with high-resolution ultrasound in otolaryngological practice. Eur Arch Otorhinolaryngol. 2017 Aug;274(8):3231-3240. doi: 10.1007/s00405-017-4636-2. Epub 2017 Jun 13.

    PMID: 28612315BACKGROUND

MeSH Terms

Conditions

Salivary Gland Diseases

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

galal galal, bachelor

CONTACT

+201064353435galalmuhammed28@gmail.com

mostafa ahmed, phd

CONTACT

+20882413280mostafaharera@aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicible investigator

Study Record Dates

First Submitted

September 30, 2018

First Posted

November 20, 2018

Study Start

December 1, 2018

Primary Completion

September 1, 2020

Study Completion

October 1, 2020

Last Updated

November 20, 2018

Record last verified: 2018-11