Protein Classifier for Thyroid Indeterminate Nodules | NCT04477798

Studies
Protein Classifier for Thyroid Indeterminate Nodules

NCT04477798

Sponsor

Luo Dingcun

Status

Unknown status

Last Update Posted

Jul 20, 2020Actual

Enrollment

320Estimated

Phase

Not Applicable

Conditions

Thyroid Nodule

Interventions

PCT-DIA/MS

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Estimated

Primary Completion Date

Jul 1, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Jul 10, 2020

First Submission Date that Met QC Criteria

Jul 16, 2020

First Posted Date

Jul 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2020

Last Update Posted Date

Jul 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

320Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
PCT-DIA/MS	Diagnostic Test	PCT-DIA/MS will be validated to classify FNA biopsy specimens	PCT-DIA/MS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
protein classifier	classify thyroid indeterminate nodules as Benign or Malignant	immediately after the procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dingcun Luo	Contact	+86057156005600		wlsydxjk@163.com

Overall Officials

Name	Affiliation	Role
Dingcun Luo	First People's Hospital of Hangzhou	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hangzhou First People's Hospital Affiliated to Zhejiang University Medical College	Recruiting	Hangzhou	Zhejiang	317500	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016606	Thyroid Nodule

Ancestor Terms

ID	Term
D013964	Thyroid Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided