Leptin Levels in Papillary Thyroid Cancer (LL-PTC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01659385
First received: August 3, 2012
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition
Thyroid Cancer, Papillary
Leptin Levels

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Assessment of Serum Leptin Levels in Females With Papillary Thyroid Carcinoma, Benign Thyroid Nodules, and Normal Controls

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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. [ Time Frame: During Study ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: August 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659385

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Whitney Goldner, MD University of Nebraska
  More Information

No publications provided

Responsible Party: University of Nebraska
ClinicalTrials.gov Identifier: NCT01659385     History of Changes
Other Study ID Numbers: 276-12-EP
Study First Received: August 3, 2012
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014