Diagnostic Significance of CTCs in Patients With Thyroid Nodules (Circulating Tumor Cells) (CTCs)
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|ClinicalTrials.gov Identifier: NCT03772496|
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Nodule Diagnoses Disease||Diagnostic Test: circulating tumor cells test Diagnostic Test: Fine needle aspiration biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
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
|Contact: jie liu, MDfirstname.lastname@example.org|
|Cancer Hospital, Chinese Academy of Medical Science||Recruiting|
|Beijing, Beijing, China, 100021|
|Contact: jie liu, MD 8610-87787180|
|Principal Investigator:||jie liu, MD||Cancer Hospital, Chinese Academy of Medical Science|