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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Persons That Are Vitamin D Deficient in the Thyroid Nodule, Thyroid Cancer in Remission, and the Active Thyroid Cancer Groups. | 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. | Within 12 months of enrollment in thyroid cancer collaborative registry (TCCR) database |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Name | Affiliation | Role |
|---|---|---|
| Nathan W Laney, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | National Cancer Institute 2006 Handbook, National Cancer Institute, Bethesda, MD. http://obf.cancer.gov/financial/attachments/06Factbk.pdf. | ||
| 16380576 | Background | Garland CF, Garland FC, Gorham ED, Lipkin M, Newmark H, Mohr SB, Holick MF. The role of vitamin D in cancer prevention. Am J Public Health. 2006 Feb;96(2):252-61. doi: 10.2105/AJPH.2004.045260. Epub 2005 Dec 27. | |
| 17556697 |
| Label | URL |
|---|---|
| SEER Database. | View source |
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Individuals who had agreed to participate in the TCCR and who had also given a blood sample were included in sequential order.
Individuals (at University of Nebraska Medical Center)were selected from a thyroid tumor and cancer collaborative registry (TCCR), database & biospecimen bank, started March 2008. We achieved a sample size of 111 subjects with 24 patients with active thyroid cancer, 45 patients with thyroid cancer in remission and 42 patients with thyroid nodules.
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| ID | Title | Description |
|---|---|---|
| FG000 | Thyroid Nodules | |
| FG001 | Thyroid Cancer in Remission | |
| FG002 | Active Thyroid Cancer |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Thyroid Nodules | |
| BG001 | Thyroid Cancer in Remission | |
| BG002 | Active Thyroid Cancer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Persons That Are Vitamin D Deficient in the Thyroid Nodule, Thyroid Cancer in Remission, and the Active Thyroid Cancer Groups. | 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. | This study is a pilot study to provide preliminary data. Per protocol, we accrued 37% of the sample size needed for a fully powered study. Using the outcome "the proportion of persons with "vitamin D deficiency", a sample size of 160 subjects (64 nodule, 64 remission, and 32 active) would achieve an 80% power to detect an effect size of 0.25. | Posted | Number | participants | Within 12 months of enrollment in thyroid cancer collaborative registry (TCCR) database |
|
breach of confidentiality
This is a study evaluating stored blood from an established biobank. There was no risk to the patient, except the potential breach of confidentiality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thyroid Nodules |
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The trial limitations include that it was mostly done on Caucasian subjects; the controls were those with thyroid nodules not subjects without any thyroid disease; the sample size was small; & a small number of Vit D assays used different methods.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Whitney S Goldner, MD | University of Nebraska Medical Center | 402-559-6205 | wgoldner@unmc.edu |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D016606 | Thyroid Nodule |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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Whole blood.
| Background |
| Lappe JM, Travers-Gustafson D, Davies KM, Recker RR, Heaney RP. Vitamin D and calcium supplementation reduces cancer risk: results of a randomized trial. Am J Clin Nutr. 2007 Jun;85(6):1586-91. doi: 10.1093/ajcn/85.6.1586. |
| 11075874 | Background | Ahonen MH, Tenkanen L, Teppo L, Hakama M, Tuohimaa P. Prostate cancer risk and prediagnostic serum 25-hydroxyvitamin D levels (Finland). Cancer Causes Control. 2000 Oct;11(9):847-52. doi: 10.1023/a:1008923802001. |
| 17974532 | Background | Abbas S, Linseisen J, Slanger T, Kropp S, Mutschelknauss EJ, Flesch-Janys D, Chang-Claude J. Serum 25-hydroxyvitamin D and risk of post-menopausal breast cancer--results of a large case-control study. Carcinogenesis. 2008 Jan;29(1):93-9. doi: 10.1093/carcin/bgm240. Epub 2007 Oct 31. |
| 17229571 | Background | Krishnan AV, Moreno J, Nonn L, Malloy P, Swami S, Peng L, Peehl DM, Feldman D. Novel pathways that contribute to the anti-proliferative and chemopreventive activities of calcitriol in prostate cancer. J Steroid Biochem Mol Biol. 2007 Mar;103(3-5):694-702. doi: 10.1016/j.jsbmb.2006.12.051. Epub 2007 Jan 16. |
| 17723171 | Background | Welsh J. Vitamin D and prevention of breast cancer. Acta Pharmacol Sin. 2007 Sep;28(9):1373-82. doi: 10.1111/j.1745-7254.2007.00700.x. |
| 11839571 | Background | Liu W, Asa SL, Fantus IG, Walfish PG, Ezzat S. Vitamin D arrests thyroid carcinoma cell growth and induces p27 dephosphorylation and accumulation through PTEN/akt-dependent and -independent pathways. Am J Pathol. 2002 Feb;160(2):511-9. doi: 10.1016/S0002-9440(10)64870-5. |
| 15319350 | Background | Dackiw AP, Ezzat S, Huang P, Liu W, Asa SL. Vitamin D3 administration induces nuclear p27 accumulation, restores differentiation, and reduces tumor burden in a mouse model of metastatic follicular thyroid cancer. Endocrinology. 2004 Dec;145(12):5840-6. doi: 10.1210/en.2004-0785. Epub 2004 Aug 19. |
| 16314444 | Background | Khadzkou K, Buchwald P, Westin G, Dralle H, Akerstrom G, Hellman P. 25-hydroxyvitamin D3 1alpha-hydroxylase and vitamin D receptor expression in papillary thyroid carcinoma. J Histochem Cytochem. 2006 Mar;54(3):355-61. doi: 10.1369/jhc.5A6734.2005. Epub 2005 Nov 28. |
| National Cancer Institute 2006 Handbook, National Cancer Institute, Bethesda, MD. http:// | View source |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Thyroid Cancer in Remission |
| OG002 | Active Thyroid Cancer |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Thyroid Cancer in Remission | 0 | 45 | 0 | 45 |
| EG002 | Active Thyroid Cancer | 0 | 24 | 0 | 24 |
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |