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Assess Vitamin D Levels in Those With & Without Thyroid Cancer

This study has been completed.
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00719615
First received: July 17, 2008
Last updated: March 15, 2010
Last verified: March 2010
  Purpose

The purpose of this study is to evaluate Vitamin D levels in thyroid cancer patients with active disease compared with thyroid cancer patients in remission and patients with thyroid nodules.


Condition
Thyroid Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Relationship Between Vitamin D and Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Number of Persons That Are Vitamin D Deficient in the Thyroid Nodule, Thyroid Cancer in Remission, and the Active Thyroid Cancer Groups. [ Time Frame: Within 12 months of enrollment in thyroid cancer collaborative registry (TCCR) database ] [ Designated as safety issue: No ]
    We evaluated serum calcium,creatinine,albumin,and 25-hydroxyvitaminD(25-OH-D)in 42 thyroid nodule, 45 thyroid cancer in remission, & 24 active thyroid cancer patients. We also determined the number and percent of participants in each group that had vitamin D deficiency, defined as 25-OH-D < 30 ng/ml.


Biospecimen Retention:   Samples With DNA

Whole blood.


Enrollment: 111
Study Start Date: March 2008
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Thyroid Cancer in Remission Group
Thyroid Cancer-Remission Group & use of Vitamin D
Thyroid Cancer with Active Disease Group
Thyroid Cancer-Active Group & use of Vitamin D
Thyroid nodule group (no cancer) & Vit D
Thyroid nodule group without cancer and use of Vitamin D

Detailed Description:

Thyroid cancer is the most common endocrine related malignancy, increasing in incidence in recent years. There are relatively few, well known factors, both genetic and environmental, which predispose to the development of thyroid cancer. Vitamin D deficiency has been associated with other cancers, but the association between vitamin D and thyroid cancer is unknown. We plan to do a case control, pilot study to evaluate the relationship between vitamin D levels and thyroid nodules, thyroid cancer in remission, and active thyroid cancer.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The Thyroid Tumor and Cancer Collaborative Registry (TCCR) is a thyroid cancer and thyroid nodule database at the University of Nebraska Medical Center. The database serves as a registry and biospecimen bank for those who wish to participate in multidisciplinary research. The database will be accessed to query for individuals with a diagnosis of thyroid cancer, both active disease and in remission, as well as a diagnosis of thyroid nodules. Those meeting eligibility requirements will then have their registry information and stored biospecimens accessed for testing and review.

Criteria

Inclusion Criteria:

  • Cases: History of Papillary, Follicular, Follicular Variant of Papillary, or Hurthle cell thyroid cancer (both active disease and in remission).
  • Controls: Individuals with a thyroid nodule, matched to cases for age, BMI, season of vitamin D measurement.
  • Participating in University of Nebraska Medical Center Thyroid Tumor and Cancer Collaborative Registry database.

Exclusion Criteria:

  • Pregnant or breast feeding women
  • Medullary thyroid cancer
  • Anaplastic thyroid cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719615

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Nathan W Laney, MD University of Nebraska Medical Center, Department of Internal Medicine, Section of DEM
  More Information

Publications:

Responsible Party: Whitney Goldner, MD, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00719615     History of Changes
Other Study ID Numbers: 136-08-EP
Study First Received: July 17, 2008
Results First Received: January 27, 2010
Last Updated: March 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Thyroid Cancer
Thyroid Nodules
Vitamin D

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014