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

Not Applicable

• Conditions: Thyroid Nodule; Diagnoses Disease
• Interventions: Diagnostic Test: circulating tumor cells test; Diagnostic Test: Fine needle aspiration biopsy

• Registration Number: NCT03772496
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief 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.

Study Timeline

• Study Start: 2018-07-25
• Study First Submitted: 2018-11-23
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-11
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-14
• Last Update Posted: 2019-09-17
• Primary Completion: 2019-12-20
• Study Completion: 2020-02-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
circulating tumor cells	Fine needle aspiration biopsy	circulating tumor cells test and FNAB will be performed at the same time
circulating tumor cells	circulating tumor cells test	circulating tumor cells test and FNAB will be performed at the same time

Primary Outcome Measures

Name	Time	Method
post-operative pathology	10 days after surgery	Patients with malignant results of FNAB (Bethesda V and VI)non-diagnostic results of FNAB (Bethesda class I , III, IV)will be suggested to undergo surgery. Those patients who underwent surgery are enrolled in our study and are performed a post-operative pathology, which have a higher evidence rank than FNAB. According to post-operative pathology, any type of thyroid carcinoma is defined as malignant, and patients who have not been strong enough to be diagnosed with carcinoma is defined as benign disease.
diagnostic results of FNAB	10 days after FNAB	The result of FNAB are classified by Bethesda rating system. Bethesda class I is considered the sample is not qualified, Bethesda class II is defined as benign, Bethesda class III and IV are defined as non-diagnostic result, which need further verified by surgery.Bethesda class V and VI are defined as malignant.

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Science; 🇨🇳 Beijing, Beijing, China