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

NCT ID: NCT03772496

Last Updated: 2019-09-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-25
• Study Completion Date: 2020-02-20

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.

Conditions

Thyroid Nodule; Diagnoses Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

circulating tumor cells

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

Group Type: EXPERIMENTAL

circulating tumor cells test

Intervention Type: DIAGNOSTIC_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

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role: collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role: collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

liu jie

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

jie liu, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital Chinese Academy of Medical Science

Locations

Cancer Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

jie liu, MD

Role: CONTACT

liujie10-11@vip.163.com

8610-87787180

Facility Contacts

jie liu, MD

Role: primary

8610-87787180

Other Identifiers

S0006YIO

Identifier Type: -

Identifier Source: org_study_id