NCT04312646

Brief Summary

Thyroid nodules are a common finding in the general population,however, they are mostly unpalpable and usually discovered either during neck ultrasound (US) examination or by pathological examination at autopsy. They are found in about 8% of adults. Most thyroid nodules ''incidentalomas" are benign, however 7% may be malignant. Early detection of thyroid cancer helps in early treatment and better survival US is an accurate method for detection of thyroid nodules; however, US has a low accuracy in differentiating between benign from malignant thyroid nodules . US could suggest a malignancy likelihood criteria of a thyroid nodule, such as hypoechogenicity, increased intranodular vascularity, irregular margins, microcalcifications, absent halo, and a taller-than-wide shape measured in the transverse dimension.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

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

March 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 16, 2020

Last Update Submit

March 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • To evaluate the role of Elastography in differentiation between benign and malignant thyroid nodules

    by its additional information over the classic gray scale and color Doppler ultrasound

    one year

Study Arms (1)

patients with thyroid nodules

Device: Elastography .

Interventions

Performance of US, elastography

patients with thyroid nodules

Eligibility Criteria

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

patients with solitary thyroid nodule

You may qualify if:

  • solitary nodule on clinical or ultrasound examination

You may not qualify if:

  • Patients received any medical treatment or chemo or radiotherapy.
  • Patients underwent fine needle aspiration cytology or biopsy
  • Nodules with calcification and cystic changes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.

    PMID: 25651787BACKGROUND

MeSH Terms

Conditions

Thyroid Nodule

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 18, 2020

Study Start

April 1, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2022

Last Updated

March 18, 2020

Record last verified: 2020-03