NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
Prospective, Blinded, Multi-center Clincal Study of NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
1 other identifier
observational
400
1 country
7
Brief Summary
The purpose of this study is to evaluate the accuracy of Thyroscan in the differential diagnosis of benign and malignant thyroid nodules with suspecious ultrasound features
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Shorter than P25 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2021
CompletedFirst Posted
Study publicly available on registry
August 27, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedSeptember 13, 2021
September 1, 2021
9 months
August 25, 2021
September 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluation of Thyroscan's performance in diagnosing thyroid nodules
To explore the sensitivity, specificity, positive predictive value, negative predictive value, consistency and Kappa value of Thyroscan in the diagnosis of thyroid nodules with ultrasound features classified as C-TIRADS category 3/4a.
June,2022
Secondary Outcomes (2)
To compared with cytopathology and Thyroscan in diagnosing thyroid nodules.
June,2022
To explore the inter-observer heterogeneity when reviewing fine needle aspiration biopsy(FNAB) by two senior cytopathologists.
June,2022
Other Outcomes (2)
To explore the cost-effectiveness analysis of Thyroscan.
June,2022
To reveals the correlation between molecular landscape and clinical-pathological characteristics of thyroid nodules.
June,2022
Study Arms (1)
Ultrasound findings of thyroid nodules classified as type 3 and 4a of TIRADS
Interventions
To evaluate the accuracy of Thyroscan in the differential diagnosis of benign and malignant thyroid nudules with abnormal ultrasound features.
Eligibility Criteria
Patients that ultrasound scan identified at least one thyroid nodule, which was classified as category 3 and 4a according to the C-TIRADS guideline.
You may qualify if:
- Patients sign the informed consent form for participating in the reasearch study.
- Patient's age is 18 years or older.
- Ultrasound showed at least one thyroid nodule, and it was classified as C-TIRADS Category 3/4a.
- The surgeon has evaluated the indications for surgery, and the subject is willing to receive surgical intervention in the medical institution.
- Surgical indications include but are not limited to one of the following conditions: 1) Thyroid nodules are compressed or affect aesthetics; 2) The patient's subjective wishes require surgical removal of the nodules; 3) FNA samples with indeterminate cytology are classified as Bethesda III and IV, requiring diagnostic surgery; 4) After the investigator's assessment, there are other surgical indications.
- Preoperative FNAB to obtain sufficient cells to meet FNA samples with indeterminate cytology are classified as Bethesda III and IV.
- The final pathological diagnosis is obtained after surgury.
You may not qualify if:
- The subject has a history of thyroid tumor.
- The subject has swollen lymph nodes in the central area or/and lateral neck area.
- The subject is not suitable for fine-needle aspiration biopsy and surgical treatment due to other conditions such as comorbid diseases.
- FNAB interprets the thyroid nodule as Bethesda V and VI categories.
- Subjects who intend to receive the radiofrequency ablation therapy.
- Other conditions determined by the researcher that do not meet the criteria of enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigen Biotechlead
- Tianjin Medical University Cancer Institute and Hospitalcollaborator
- Guangdong Provincial People's Hospitalcollaborator
- RenJi Hospitalcollaborator
- Zhejiang Provincial People's Hospitalcollaborator
- The First People's Hospital of Changzhoucollaborator
- Shenzhen People's Hospitalcollaborator
- Zhongshan People's Hospital, Guangdong, Chinacollaborator
Study Sites (7)
Zhongshan City People's Hospital
Zhongshan, Guangdong, 528400, China
The First Peple's Hospital of Changzhou
Changzhou, Jiangsu, 213000, China
Guangdong Provincial People's Hospital
Guangzhou, 510000, China
Zhejiang Provincial People's Hospital
Hangzhou, 310000, China
Shanghai Jiaotong University School of Medicine
Shanghai, 200000, China
Shenzhen People's Hospital
Shenzhen, 518000, China
Tianjin Medical University Center Hospital
Tianjin, 300000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2021
First Posted
August 27, 2021
Study Start
September 1, 2021
Primary Completion
June 1, 2022
Study Completion
June 1, 2022
Last Updated
September 13, 2021
Record last verified: 2021-09