Diagnostic Significance of CTCs in Patients With Thyroid Nodules (Circulating Tumor Cells) (CTCs)
Primary Purpose
Thyroid Nodule, Diagnoses Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
circulating tumor cells test
Fine needle aspiration biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Nodule focused on measuring fine needle aspiration biopsy, Circulating tumor cells, benign, malignant
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
Sites / Locations
- Cancer Hospital, Chinese Academy of Medical ScienceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
circulating tumor cells
Arm Description
circulating tumor cells test and FNAB will be performed at the same time
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03772496
First Posted
November 23, 2018
Last Updated
September 14, 2019
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators
China-Japan Friendship Hospital, Chinese PLA General Hospital, Beijing Chao Yang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03772496
Brief Title
Diagnostic Significance of CTCs in Patients With Thyroid Nodules (Circulating Tumor Cells)
Acronym
CTCs
Official Title
A Multicenter, Double-blind, Prospective Cohort Study of Diagnostic Significance of Circulating Tumor Cells in Patients With Thyroid Nodules
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
December 20, 2019 (Anticipated)
Study Completion Date
February 20, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators
China-Japan Friendship Hospital, Chinese PLA General Hospital, Beijing Chao Yang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule, Diagnoses Disease
Keywords
fine needle aspiration biopsy, Circulating tumor cells, benign, malignant
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
circulating tumor cells
Arm Type
Experimental
Arm Description
circulating tumor cells test and FNAB will be performed at the same time
Intervention Type
Diagnostic Test
Intervention Name(s)
circulating tumor cells test
Intervention Description
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
Intervention Name(s)
Fine needle aspiration biopsy
Intervention Description
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 Measure Information:
Title
post-operative pathology
Description
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.
Time Frame
10 days after surgery
Title
diagnostic results of FNAB
Description
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.
Time Frame
10 days after FNAB
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jie liu, MD
Phone
8610-87787180
Email
liujie10-11@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jie liu, MD
Organizational Affiliation
Cancer Hospital, Chinese Academy of Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jie liu, MD
Phone
8610-87787180
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diagnostic Significance of CTCs in Patients With Thyroid Nodules (Circulating Tumor Cells)
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