Multicenter Registry Comparing Preoperative Imaging for P... | NCT02381925

Studies
Multicenter Registry Comparing Preoperative Imaging for Primary Hyperparathyroidism

NCT02381925

Sponsor

Duke University

Status

Withdrawn

Last Update Posted

Sep 21, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Parathyroid Adenoma

Interventions

Not provided

Countries

Not provided

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

Sep 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study never opened due to funding issues

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Jun 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Mar 3, 2015

First Submission Date that Met QC Criteria

Mar 3, 2015

First Posted Date

Mar 6, 2015Estimated

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

Sep 17, 2015

Last Update Posted Date

Sep 21, 2015Estimated

Name	Class
University of California, Los Angeles	OTHER
University of Arkansas	OTHER

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 study aims are:

To compare the diagnostic performance of parathyroid four-dimensional CT (4D-CT), scintigraphy, and ultrasound in patients who underwent parathyroid surgery for primary hyperparathyroidism.
To compare 4D-CT, scintigraphy, and ultrasound for the ability to perform focused parathyroidectomy, and for rates of persistent hyperparathyroidism and complications from parathyroid surgery.

Methods The investigators will create a multicenter registry consisting of patients having parathyroid surgery for primary hyperparathyroidism from July 2009 to June 2016. Initial participating centers include Duke University Medical Center, University California Los Angeles (UCLA) and University of Arkansas for Medical Sciences (UAMS).

There will be no intervention in the patient's treatment or imaging. The management will be determined by the surgeon or clinician supervising the patient's care.

The registry will consist of patient data regarding basic demographics, history of prior neck/chest surgery or radiation, parathyroid imaging, biochemical evaluation, intraoperative surgical findings, parathyroid pathology, and surgical outcomes within the first 6 months (persistent disease, recurrent laryngeal nerve injury, and hypoparathyroidism). Data will be entered into REDCap with no PHI. The investigators expect to include 3000 patients in the registry (1000 from Duke).

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

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diagnostic performance of imaging		6 months

Secondary Outcomes

Measure	Description	Time Frame
ability to perform focused parathyroidectomy		6 months
rates of persistent hyperparathyroidism after parathyroidectomy		6 months
parathyroidectomy surgical complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients having parathyroid surgery for primary hyperparathyroidism from July 2009 to June 2016

Exclusion Criteria:

age less than 18 years
parathyroid carcinoma
secondary or tertiary hyperparathyroidism

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

The subjects will include all patients, aged 18 years or older, who underwent parathyroid surgery from July 2009 to July 2016.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D010282	Parathyroid 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