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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Thyroid Nodule; Diagnoses Disease

Treatments: Diagnostic Test: circulating tumor cells test; Diagnostic Test: Fine needle aspiration biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03772496

S0006YIO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with thyroid nodules (≤2cm) untreatment FNAB suggested by ultrasound

Exclusion criteria

• the history of other cancer the history of thyroid surgery Bethesda class 3 without surgery

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

circulating tumor cells

Experimental group

Description:

circulating tumor cells test and FNAB will be performed at the same time

Treatment:

Diagnostic Test: circulating tumor cells test

Diagnostic Test: Fine needle aspiration biopsy