Differential Diagnosis and Clinical Treatment Strategies... | NCT02953288

Studies
Differential Diagnosis and Clinical Treatment Strategies of Thyroid Nodules.

NCT02953288

Sponsor

Shanghai 10th People's Hospital

Status

Unknown status

Last Update Posted

Nov 2, 2016Estimated

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Thyroid Cancer

Interventions

Not provided

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

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Jun 2017Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Nov 1, 2016

First Submission Date that Met QC Criteria

Nov 1, 2016

First Posted Date

Nov 2, 2016Estimated

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

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhang Manna, Department of Endocrinology, Shanghai 10th People's HospitalPrincipal Investigator

Lead Sponsor

Shanghai 10th People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To investigate the genetic mutations of patients with thyroid carcinoma and find molecular targets for therapy.

Detailed Description

In previous studies, we have found highly prevalent TERT promoter mutations in aggressive thyroid cancers. So we plan to perform further research to investigate the genetic mutations of patients with thyroid carcinoma and find molecular targets for therapy.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Benign thyroid nodules		Benign thyroid nodules
Thyroid Carcinoma		Thyroid Carcinoma

Interventions

Not provided

Measure	Description	Time Frame
Gene sequencing		2 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with thyroid nodule

Exclusion Criteria:

Coagulant function abnormality
pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patient with thyroid nodule

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shen Qu	Sanghai Tenth People's Hospital, Shanghai, China	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology, Shanghai Tenth People's Hospital		Shanghai	Shanghai Municipality	200070	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013964	Thyroid Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided