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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772496
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : September 17, 2019
Sponsor:
Collaborators:
China-Japan Friendship Hospital
Chinese PLA General Hospital
Beijing Chao Yang Hospital
Information provided by (Responsible Party):
liu jie, 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.

Condition or disease Intervention/treatment Phase
Thyroid Nodule Diagnoses Disease Diagnostic Test: circulating tumor cells test Diagnostic Test: Fine needle aspiration biopsy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Multicenter, Double-blind, Prospective Cohort Study of Diagnostic Significance of Circulating Tumor Cells in Patients With Thyroid Nodules
Actual Study Start Date : July 25, 2018
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : February 20, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arm Intervention/treatment
Experimental: circulating tumor cells
circulating tumor cells test and FNAB will be performed at the same time
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.




Primary Outcome Measures :
  1. post-operative pathology [ Time Frame: 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.

  2. diagnostic results of FNAB [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772496


Contacts
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Contact: jie liu, MD 8610-87787180 liujie10-11@vip.163.com

Locations
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China, Beijing
Cancer Hospital, Chinese Academy of Medical Science Recruiting
Beijing, Beijing, China, 100021
Contact: jie liu, MD    8610-87787180      
Sponsors and Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
China-Japan Friendship Hospital
Chinese PLA General Hospital
Beijing Chao Yang Hospital
Investigators
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Principal Investigator: jie liu, MD Cancer Hospital, Chinese Academy of Medical Science
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Responsible Party: liu jie, Clinical Professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03772496    
Other Study ID Numbers: S0006YIO
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by liu jie, Cancer Institute and Hospital, Chinese Academy of Medical Sciences:
fine needle aspiration biopsy
Circulating tumor cells
benign
malignant
Additional relevant MeSH terms:
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Neoplastic Cells, Circulating
Thyroid Nodule
Thyroid Diseases
Endocrine System Diseases
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms