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

5. september 2021 opdateret af: Rigen Biotech

Prospective, Blinded, Multi-center Clincal Study of NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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 14~42 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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

400

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
      • Guangzhou, Kina, 510000
        • Ikke rekrutterer endnu
        • Guangdong Provincial People's Hospital
        • Kontakt:
          • Guan Haixia
      • Hangzhou, Kina, 310000
        • Ikke rekrutterer endnu
        • Zhejiang Provincial People's Hospital
        • Kontakt:
          • Zheng Chuanmin
      • Shanghai, Kina, 200000
        • Ikke rekrutterer endnu
        • Shanghai Jiaotong University School of Medicine
        • Kontakt:
          • Wang Zhuoying
      • Shenzhen, Kina, 518000
        • Ikke rekrutterer endnu
        • ShenZhen People's Hospital
      • Tianjin, Kina, 300000
        • Rekruttering
        • Tianjin Medical University Center Hospital
        • Kontakt:
          • Zheng Xiangqian
    • Guangdong
      • Zhongshan, Guangdong, Kina, 528400
        • Ikke rekrutterer endnu
        • Zhongshan City People's Hospital
    • Jiangsu
      • Changzhou, Jiangsu, Kina, 213000
        • Ikke rekrutterer endnu
        • The First Peple's Hospital of Changzhou
        • Kontakt:
          • Li Qing

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients that ultrasound scan identified at least one thyroid nodule, which was classified as category 3 and 4a according to the C-TIRADS guideline.

Beskrivelse

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-TIRADS Category 3/4a.
  4. The surgeon has evaluated the indications for surgery, and the subject is willing to receive 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 subjective wishes require surgical removal of the nodules; 3) FNA samples with indeterminate cytology are classified as Bethesda III and IV, requiring diagnostic surgery; 4) After the investigator's assessment, there are other surgical indications.
  6. Preoperative FNAB to obtain sufficient cells to meet FNA samples with indeterminate cytology are classified as Bethesda III and IV.
  7. The final pathological diagnosis is obtained after surgury.

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 treatment due 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 of enrollment.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Ultrasound findings of thyroid nodules classified as type 3 and 4a of TIRADS
Diagnostisk test: Thyroscan
To evaluate the accuracy of Thyroscan in the differential diagnosis of benign and malignant thyroid nudules with abnormal ultrasound features.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To evaluation of Thyroscan's performance in diagnosing thyroid nodules
Tidsramme: June,2022
To explore the sensitivity, specificity, positive predictive value, negative predictive value, consistency and Kappa value of Thyroscan in the diagnosis of thyroid nodules with ultrasound features classified as C-TIRADS category 3/4a.
June,2022

Sekundære resultatmål

Resultatmål
Tidsramme
To compared with cytopathology and Thyroscan in diagnosing thyroid nodules.
Tidsramme: June,2022
June,2022
To explore the inter-observer heterogeneity when reviewing fine needle aspiration biopsy(FNAB) by two senior cytopathologists.
Tidsramme: June,2022
June,2022

Andre resultatmål

Resultatmål
Tidsramme
To explore the cost-effectiveness analysis of Thyroscan.
Tidsramme: June,2022
June,2022
To reveals the correlation between molecular landscape and clinical-pathological characteristics of thyroid nodules.
Tidsramme: June,2022
June,2022

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Rigen Biotech

Samarbejdspartnere

RenJi Hospital
Tianjin Medical University Cancer Institute and Hospital
Guangdong Provincial People's Hospital
Shenzhen People's Hospital
Zhejiang Provincial People's Hospital
Zhongshan People's Hospital, Guangdong, China
The First People's Hospital of Changzhou

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. september 2021

Primær færdiggørelse (Forventet)

1. juni 2022

Studieafslutning (Forventet)

1. juni 2022

Datoer for studieregistrering

Først indsendt

25. august 2021

Først indsendt, der opfyldte QC-kriterier

25. august 2021

Først opslået (Faktiske)

27. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RigenBio

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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