Predictive Factors of Clinical, Laboratory and Imaging Fi... | NCT01074684

Studies
Predictive Factors of Clinical, Laboratory and Imaging Findings Routinely Used in Diagnosing Thyroid Cancer

NCT01074684

Sponsor

National Cancer Institute, Naples

Status

Completed

Last Update Posted

Mar 24, 2023Actual

Enrollment

959Actual

Phase

Not provided

Conditions

Thyroid Cancer

Interventions

Not provided

Countries

Italy

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Dec 1, 2021Actual

Completion Date

Dec 1, 2021Actual

First Submitted Date

Feb 23, 2010

First Submission Date that Met QC Criteria

Feb 23, 2010

First Posted Date

Feb 24, 2010Estimated

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

Mar 23, 2023

Last Update Posted Date

Mar 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to describe the correlation between the cytohistology exam of patients undergoing thyroid surgery, and the predictive values of: suspicious clinical findings, preoperative thyroid imaging, and the incidence of thyroid cancer in cytologically negative nodes.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

959Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
positive predictive value of preoperative suspicious clinical, laboratory and imaging findings		at baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consecutive patients presenting for thyroid disease (palpable nodules)
Indication for surgery
Age > 18 years
Signed informed consent for surgery
Signed informed consent for data collection

Exclusion Criteria:

Concurrent condition that contraindicates surgery
Clinical or radiologic evidence of locally advanced tumor
Clinical or radiologic evidence of metastatic lymph nodes or distant metastases
Nonpalpable nodes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients with palpable thyroid nodules with indication for surgery (positive cytology, 2 consecutive inconclusive cytologies, or negative cytology with at least 2 of the following: previous exposure to neck radiation, calcitonin greater than twice normal values, positive pentagastrin test, or irregular margins or hypoechogenicity on ultrasound.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luciano Pezzulo, M.D.	National Cancer Institute, Naples	Principal Investigator
Maria Grazia Chiofalo, M.D.	National Cancer Institute, Naples	Principal Investigator
Massimo Di Maio, M.D.	National Cancer Institute, Naples	Principal Investigator
Francesco Perrone, M.D., Ph.D.	National Cancer Institute, Naples	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Università di Cagliari		Cagliari			Italy
Azienda Ospedaliera Unviersitaria Careggi - Firenze

Condition Browse Module

MeSH Terms

ID	Term
D013964	Thyroid Neoplasms
D004194	Disease

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