Assess Vitamin D Levels in Those With & Without Thyroid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00719615
Recruitment Status : Completed
First Posted : July 21, 2008
Results First Posted : March 30, 2010
Last Update Posted : June 3, 2015
Information provided by:
University of Nebraska

Brief Summary:
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 or disease
Thyroid Cancer

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.

Study Type : Observational
Actual Enrollment : 111 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Relationship Between Vitamin D and Thyroid Cancer
Study Start Date : March 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00719615

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

Additional Information:
National Cancer Institute 2006 Handbook, National Cancer Institute, Bethesda, MD.

Responsible Party: Whitney Goldner, MD, University of Nebraska Medical Center Identifier: NCT00719615     History of Changes
Other Study ID Numbers: 136-08-EP
First Posted: July 21, 2008    Key Record Dates
Results First Posted: March 30, 2010
Last Update Posted: June 3, 2015
Last Verified: March 2010

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

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