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NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules

NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300071114
Enrollment
Unknown
Registered
2023-05-05
Start date
2023-05-08
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid carcinoma

Interventions

Index test:NGS-based Thyroscan Genomic Classifier

Sponsors

Tianjin Medical University Cancer Institute &Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Negative expected value;sensitiveness;specificity;Positive predictive value;consistence;Kappa value;

Countries

China

Contacts

Public ContactXiangqian Zheng

Tianjin Medical University Cancer Institute &Hospital

xiangqian_zheng@163.com+86 18622220506

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026