NCT04477798

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

July 10, 2020

Last Update Submit

July 16, 2020

Conditions

Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

  • protein classifier

    classify thyroid indeterminate nodules as Benign or Malignant

    immediately after the procedure

Study Arms (1)

PCT-DIA/MS

EXPERIMENTAL

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

Diagnostic Test: PCT-DIA/MS

Interventions

PCT-DIA/MSDIAGNOSTIC_TEST

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

PCT-DIA/MS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients without operation;
  • Patients with insufficient FNA sample size (judged by the laboratory).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, 317500, China

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Dingcun Luo

    First People's Hospital of Hangzhou

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dingcun Luo

CONTACT

+86057156005600wlsydxjk@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
SPONSOR INVESTIGATOR
PI Title
vice president of hospital

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 20, 2020

Study Start

August 1, 2020

Primary Completion

July 1, 2021

Study Completion

December 31, 2021

Last Updated

July 20, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)