Assess Vitamin D Levels in Those With & Without Thyroid Cancer
This study has been completed.
Sponsor:
University of Nebraska
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00719615
First received: July 17, 2008
Last updated: March 15, 2010
Last verified: March 2010
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| Tracking Information | |||||
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| First Received Date ICMJE | July 17, 2008 | ||||
| Last Updated Date | March 15, 2010 | ||||
| Start Date ICMJE | March 2008 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
Assess percentage of persons with vitamin D levels in the deficient range (25-OH-D <30ng/ml) with active thyroid cancer compared to those in remission and controls. [ Time Frame: Within 12 months of enrollment in thyroid cancer collaborative registry database ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00719615 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assess Vitamin D Levels in Those With & Without Thyroid Cancer | ||||
| Official Title ICMJE | The Relationship Between Vitamin D and Thyroid Cancer | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Whole blood. |
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| 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. |
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| Condition ICMJE | Thyroid Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 111 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 19 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00719615 | ||||
| Other Study ID Numbers ICMJE | 136-08-EP | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Whitney Goldner, MD, University of Nebraska Medical Center | ||||
| Study Sponsor ICMJE | University of Nebraska | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Nebraska | ||||
| Verification Date | March 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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