NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules

Last updated: September 5, 2021
Sponsor: Rigen Biotech
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thyroid Cancer

Thyroid Disease

Treatment

N/A

Clinical Study ID

NCT05025046
RigenBio
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the accuracy of Thyroscan in the differential diagnosis of benign and malignant thyroid nodules with suspecious ultrasound features

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients sign the informed consent form for participating in the reasearch study.
  2. Patient's age is 18 years or older.
  3. Ultrasound showed at least one thyroid nodule, and it was classified as C-TIRADSCategory 3/4a.
  4. The surgeon has evaluated the indications for surgery, and the subject is willing toreceive surgical intervention in the medical institution.
  5. Surgical indications include but are not limited to one of the following conditions:
  1. Thyroid nodules are compressed or affect aesthetics; 2) The patient's subjectivewishes require surgical removal of the nodules; 3) FNA samples with indeterminatecytology are classified as Bethesda III and IV, requiring diagnostic surgery; 4) Afterthe investigator's assessment, there are other surgical indications.
  1. Preoperative FNAB to obtain sufficient cells to meet FNA samples with indeterminatecytology are classified as Bethesda III and IV.
  2. The final pathological diagnosis is obtained after surgury.

Exclusion

Exclusion Criteria:

  1. The subject has a history of thyroid tumor.
  2. The subject has swollen lymph nodes in the central area or/and lateral neck area.
  3. The subject is not suitable for fine-needle aspiration biopsy and surgical treatmentdue to other conditions such as comorbid diseases.
  4. FNAB interprets the thyroid nodule as Bethesda V and VI categories.
  5. Subjects who intend to receive the radiofrequency ablation therapy.
  6. Other conditions determined by the researcher that do not meet the criteria ofenrollment.

Study Design

Total Participants: 400
Study Start date:
September 01, 2021
Estimated Completion Date:
June 30, 2022

Study Description

The prevalence of thyroid nodules by high-resolution ultrasound can be as high as 20%, though most of them are benign lesions, only about 5%15% are malignant lesions. Based on 1.4 billion population in China, there are approximately 280 million thyroid nodule carriers, of which approximately 1442 million are potential patients with thyroid cancer. Now thyroid cancer is the fastest growing cancer and the 4th most common cancer in women in China. Therefore, the key point in the evaluation of thyroid nodules is the differential diagnosis of benign and malignant nodules. At present, the commonly used imaging and cytological diagnostic techniques for thyroid nodules include ultrasound and ultrasound-guided fine needle aspiration biopsy (FNAB), as well as emerging molecular diagnostic techniques.

The purpose of this study is to evaluate the accuracy of Thyroscan in the diagnosis of benign and malignant thyroid nodules with suspecious ultrasound features. For patients who have signed an informed consent, the subjects undergo fine needle aspiration of thyroid nodules classified as C-TIRADS catagories 3 or 4a under the guidance of ultrasound or palpation before receiving surgical treatment. One needle is used to prepare cytological smear, and one needle is preserved and sent to Thyroscan detection. The histopathological is obtained as the "gold standerd" after surgical treatment.

Connect with a study center

  • Zhongshan City People's Hospital

    Zhongshan, Guangdong 528400
    China

    Site Not Available

  • The First Peple's Hospital of Changzhou

    Changzhou, Jiangsu 213000
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou, 510000
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou, 310000
    China

    Site Not Available

  • Shanghai Jiaotong University School of Medicine

    Shanghai, 200000
    China

    Site Not Available

  • Shenzhen People's Hospital

    Shenzhen, 518000
    China

    Site Not Available

  • Tianjin Medical University Center Hospital

    Tianjin, 300000
    China

    Active - Recruiting

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