Protein Classifier for Thyroid Indeterminate Nodules

NCT ID: NCT04477798

Last Updated: 2020-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-12-31

Brief Summary

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In multi-center, prospective, double-blind cohorts, PCT-DIA/MS protein classifier supported by artificial neural networks will be validated to classify thyroid indeterminate nodules.

Detailed Description

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Conditions

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Thyroid Nodule

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PCT-DIA/MS

PCT-DIA/MS protein classifier supported by artificial neural networks will be validated to classify thyroid indeterminate nodules

Group Type EXPERIMENTAL

PCT-DIA/MS

Intervention Type DIAGNOSTIC_TEST

PCT-DIA/MS will be validated to classify FNA biopsy specimens

Interventions

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PCT-DIA/MS

PCT-DIA/MS will be validated to classify FNA biopsy specimens

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Patients with aged 18 to 70 years old;
2. Patients with thyroid nodules who have not been treated with drugs;
3. Patients who were diagnosed as Bethesda III and IV by cytology and pathology before operation;
4. Patients who underwent total / partial thyroidectomy and had histopathological reports of corresponding cellular pathological punctured nodules;
5. Patients voluntarily participate in the study after informed consent.

Exclusion Criteria

1. Patients without operation;
2. Patients with insufficient FNA sample size (judged by the laboratory).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luo Dingcun

OTHER

Sponsor Role lead

Responsible Party

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Luo Dingcun

vice president of hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dingcun Luo

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital of Hangzhou

Locations

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Hangzhou First People's Hospital Affiliated to Zhejiang University Medical College

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dingcun Luo

Role: CONTACT

+86057156005600

Facility Contacts

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Dingcun Luo

Role: primary

Other Identifiers

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ZhejiangU20200701

Identifier Type: -

Identifier Source: org_study_id

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