Leptin Levels in Papillary Thyroid Cancer | NCT01659385

Studies
Leptin Levels in Papillary Thyroid Cancer

NCT01659385

Sponsor

University of Nebraska

Status

Completed

Last Update Posted

Sep 6, 2023Actual

Enrollment

18Actual

Phase

Not provided

Conditions

Thyroid Cancer, Papillary
Leptin Levels

Interventions

Not provided

Countries

United States

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

Aug 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

Aug 7, 2012Actual

Primary Completion Date

Apr 25, 2013Actual

Completion Date

Apr 25, 2013Actual

First Submitted Date

Aug 3, 2012

First Submission Date that Met QC Criteria

Aug 6, 2012

First Posted Date

Aug 7, 2012Estimated

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

Aug 31, 2023

Last Update Posted Date

Sep 6, 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 evaluate Leptin levels in females, in the setting of papillary thyroid cancer, benign thyroid nodules, and in normal females without thyroid disease.

Detailed Description

There will be three groups in this study, but 2 of the groups are part of another study so will only recruit normal controls.

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

18Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
evaluating Leptin level Evaluating Serum Leptin Levels Between 3 Groups. One Group with Papillary Thyroid Carcinoma. One Group With Benign Nodules. One Group with Normal Thyroid.	Assessing serum leptin levels in females with treated papillary thyroid carcinoma and compared to females with proven benign thyroid nodules and females with normal thyroid glands. All groups were matched by gender, age, and BMI to limit confounders.	During Study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female
Age>/- 19
Not currently pregnant or lactating
Normal thyroid gland by history

Exclusion Criteria:

Male Gender
Pregnancy
Lactation
Age below 19
Abnormal thyroid gland by history
Abnormal thyroid gland by structure using ultrasound
Abnormal thyroid gland by function using TSH, Free T4

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Females with no prior history of thyroid disease and not on thyroid medications.

Active recruitment will be for normal controls only. They will be age and weight/height matched to females with prior diagnosis of thyroid cancer or thyroid nodules who are already part of another study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Whitney Goldner, MD	University of Nebraska	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Nebraska Medical Center		Omaha	Nebraska	68198	United States

Condition Browse Module

MeSH Terms

ID	Term
D000077273	Thyroid Cancer, Papillary

Ancestor Terms

ID	Term
D000231	Adenocarcinoma, Papillary
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial

Browse Leaves

Not provided

Browse Branches

Not provided