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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The prevalence of thyroid nodules by high-resolution ultrasound can be as high as 20%, though most of them are benign lesions, only about 5%-15% are malignant lesions. Based on 1.4 billion population in China, there are approximately 280 million thyroid nodule carriers, of which approximately 14-42 million are potential patients with thyroid cancer. Now thyroid cancer is the fastest growing cancer and the 4th most common cancer in women in China. Therefore, the key point in the evaluation of thyroid nodules is the differential diagnosis of benign and malignant nodules. At present, the commonly used imaging and cytological diagnostic techniques for thyroid nodules include ultrasound and ultrasound-guided fine needle aspiration biopsy (FNAB), as well as emerging molecular diagnostic techniques.
The purpose of this study is to evaluate the accuracy of Thyroscan in the diagnosis of benign and malignant thyroid nodules with suspecious ultrasound features. For patients who have signed an informed consent, the subjects undergo fine needle aspiration of thyroid nodules classified as C-TIRADS catagories 3 or 4 under the guidance of ultrasound or palpation before receiving surgical treatment. One needle is used to prepare cytological smear, and one needle is preserved and sent to Thyroscan detection.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Hangzhou, China, 310000
- Zhejiang Provincial People's Hospital
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Shanghai, China, 200000
- Shanghai Jiaotong University School of Medicine
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Tianjin, China, 300000
- Tianjin Medical University Center Hospital
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Jiangsu
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Changzhou, Jiangsu, China, 213000
- The First Peple's Hospital of Changzhou
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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 3/4.
- The surgeon has confirmed surgical indication and the subject is willing to undergo the planned surgical intervention at the participating medical institution; or cytology results are benign, and the nodule(s) have remained clinically stable-defined as absence of new high-risk ultrasound features and no significant change in size on serial imaging.
- 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.
Exclusion Criteria:
- The subject has a history of thyroid tumor.
- The subject is not suitable for fine-needle aspiration biopsy and surgical treatment due to other conditions such as comorbid diseases.
- Subjects who intend to receive the radiofrequency ablation therapy.
- Other conditions determined by the researcher that do not meet the criteria of enrollment.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Ultrasound findings of thyroid nodules classified as type 3 and 4 of C-TIRADS
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To evaluate the accuracy of Thyroscan in the differential diagnosis of benign and malignant thyroid nudules with abnormal ultrasound features.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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To evaluation of Thyroscan's performance in diagnosing thyroid nodules
Tijdsspanne: At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.
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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 3/4.
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At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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To compared with cytopathology and Thyroscan in diagnosing thyroid nodules.
Tijdsspanne: At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.
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At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.
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Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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To reveals the correlation between molecular landscape and clinical-pathological characteristics of thyroid nodules.
Tijdsspanne: At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.
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At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- RigenBio
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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