Clinical trial NCT03772496: Diagnostic Significance of CTCs in Patients With Thyroid Nodules (Circulating Tumor Cells)
Official title: A Multicenter, Double-blind, Prospective Cohort Study of Diagnostic Significance of Circulating Tumor Cells in Patients With Thyroid Nodules
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Nodule
Diagnoses Disease
Keywords: fine needle aspiration biopsy
Circulating tumor cells
benign
malignant
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: China-Japan Friendship Hospital
name: Chinese PLA General Hospital
name: Beijing Chao Yang Hospital
First posted: 2018-12-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: post-operative pathology
timeFrame: 10 days after surgery
measure: diagnostic results of FNAB
timeFrame: 10 days after FNAB
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Science
state: Beijing
Study officials:
affiliation: Cancer Hospital, Chinese Academy of Medical Science
name: jie liu, MD
role: PRINCIPAL_INVESTIGATOR
References: