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

NCT03772496 | Unknown

• 1 other identifier: S0006YIO
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Nodule; Diagnoses Disease

Keywords

fine needle aspiration biopsy; Circulating tumor cells; benign; malignant

Outcome Measures

Primary Outcomes (2)

• 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.

  10 days after surgery

• 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.

  10 days after FNAB

Study Arms (1)

circulating tumor cells

EXPERIMENTAL

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

Diagnostic Test: circulating tumor cells test; Diagnostic Test: Fine needle aspiration biopsy

Interventions

circulating tumor cells test 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.

circulating tumor cells

Fine needle aspiration biopsy 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.

circulating tumor cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with thyroid nodules (≤2cm) untreatment FNAB suggested by ultrasound

You may not qualify if:

• the history of other cancer the history of thyroid surgery Bethesda class 3 without surgery

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• China-Japan Friendship Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule; Neoplastic Cells, Circulating

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• jie liu, MD

  Cancer Hospital Chinese Academy of Medical Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jie liu, MD

CONTACT

8610-87787180; liujie10-11@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: December 11, 2018
• Study Start: July 25, 2018
• Primary Completion: December 20, 2019
• Study Completion: February 20, 2020
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)