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

Diagnoses Disease Clinical Trial

— CTCs  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03772496
• Other study ID #: S0006YIO
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2018
• Est. completion date: February 20, 2020

Study information

• Verified date: September 2019
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: jie liu, MD
• Phone: 8610-87787180
• Email: liujie10-11[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 20, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diagnoses Disease
• Neoplastic Cells, Circulating
• Thyroid Diseases
• Thyroid Nodule

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Science	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing Chao Yang Hospital, China-Japan Friendship Hospital, Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-operative pathology	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.	10 days after surgery
Primary	diagnostic results of 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.	10 days after FNAB