NCT03772496

Diagnostic Significance of CTCs in Patients With Thyroid Nodules (Circulating Tumor Cells)

A Multicenter, Double-blind, Prospective Cohort Study of Diagnostic Significance of Circulating Tumor Cells in Patients With Thyroid Nodules

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Thyroid nodule patients with suggestion of fine needle aspiration biopsy (FNAB) offered by ultrasound are enrolled in the study. CTCs tested by Optimizing method and FNAB will be performed simultaneously. This is a double blind trial which pathologists and inspectors of CTCs don't know the result of each other. Surgical pathology and diagnostic results of FNAB is the primary endpoint and comparison will be made to see if CTCs combined with ultrasound can get similar diagnostic performance as FNAB. The diagnostic results of FNAB included Bethesda class II and more than V which are defined as benign and malignant, respectively.

Detailed description

Some retrospective analysises showed CTCs is considered to be valuable for diagnosis, staging, prognosis and follow-up in several types of cancers and some mRNA markers are helpful in differentiating patients with benign versus malignant thyroid disease. However, the lack of sensitivity and specificity of mRNA measurements restricted their clinical application. The aim of this study is to see if optimizing test method combined with ultrasound can get similar diagnostic performance. 200 patients with thyroid nodules (≤2cm) which need to undergo FNAB will be enrolled in four centers of northern China. Patients will simultaneously undergo CTCs tests and FNAB. And following treatments will be performed according to the previous standard. Allowed by the patients, the investigators will obtain 10ml peripheral blood samples from the participants to make a CTCs test before any FNAB. The primary end point is the pathologically confirmed benign versus malignant thyroid disease, which including surgical pathology and diagnostic results of FNAB.

Conditions

• Thyroid Nodule
• Diagnoses Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	circulating tumor cells test	10 ml Peripheral blood are drawn from patients enrolled before surgery/FNAB and centrifuged to collect the peripheral blood mononuclear cells. Then, negative and positive immunomagnetic selections are used to exclude white blood cells and enrich tumor cells. After isolating mRNA, RT-PCR array is used to measure expression of target genes.
DIAGNOSTIC_TEST	Fine needle aspiration biopsy	patients with potential malignant thyroid nodules are performed fine needle aspiration biopsy with the aid of ultrasound. The result of FNAB were classified by Bethesda rating system.

Timeline

• Start date: 2018-07-25
• Primary completion: 2019-12-20
• Completion: 2020-02-20
• First posted: 2018-12-11
• Last updated: 2019-09-17

Locations

1 site across 1 country: China