Application of Ultrasonic Gray-scale Ratio in Differentiating Benign From Malignant Thyroid Nodules.
1 other identifier
observational
300
1 country
1
Brief Summary
According to the grades of echogenicity to evulated thyroid nodules is a subjective process and is thus influenced by the observer's judgement. The investigators first proposed the ultrasound gray-scale ratio (UGSR) to explore its efficacy for differentiating papillary thyroid microcarcinomas from small nodular goiters.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedOctober 9, 2018
October 1, 2018
1 year
July 7, 2018
October 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The diagnostic value of UGSR in differentiating benign from malignant thyroid nodules.
The accuracy, sensitivity and specificity of UGSR in differentiating benign from malignant thyroid nodules.
All the data will be uploaded in 1 year.
Secondary Outcomes (1)
The best UGSR in differentiating benign from malignant thyroid nodules.
All the data will be uploaded in 1 year.
Study Arms (2)
pathologically results
finally proved by pathologically results
evaluate by ultrasound gray-scale ratio
the results confirmed by the cut-off value of ultrasound gray-scale ratio
Interventions
RADinfo radiograph reading system was used to measure the gray-scales of PTMC, NG, and thyroid tissues at the same gain level, the UGSR values of the PTMC, NG, and thyroid tissue were calculated.
Eligibility Criteria
Patients diagnosed with thyroid nodules by ultrasound or incidentally noted on other imaging tests.
You may qualify if:
- patients diagnosed as thyroid nodule.
- homo-echogenicity of normal thyroid tissue.
- able and willing to comply with all study requirements.
You may not qualify if:
- nodules are mainly cystic or calcified.
- pathology confirmed Hashimoto's thyroiditis.
- unable or unwilling to comply with all study requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The first people's hospital of Hangzhou
Hangzhou, Zhejiang, 310006, China
Biospecimen
The patients will receive fine-needle aspiration of thyroid nodules after they have completed ultrasonic image tests. The cytological tests will be furtherly carried on in pathology department to confirm the histology of thyroid lesion.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhijiang Han, Doctor
The Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2018
First Posted
October 9, 2018
Study Start
October 1, 2018
Primary Completion
October 1, 2019
Study Completion
October 1, 2020
Last Updated
October 9, 2018
Record last verified: 2018-10