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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00719615
Other study ID # 0136-08-EP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 28, 2008
Est. completion date June 1, 2009

Study information

Verified date October 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 111
Est. completion date June 1, 2009
Est. primary completion date March 1, 2009
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Nebraska Medical Center Omaha Nebraska

Sponsors (1)

Lead Sponsor Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Am J Clin Nutr. 2008 Mar;87(3):794. — View Citation

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. — View Citation

National Cancer Institute 2006 Handbook, National Cancer Institute, Bethesda, MD. http://obf.cancer.gov/financial/attachments/06Factbk.pdf.

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
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. Within 12 months of enrollment in thyroid cancer collaborative registry (TCCR) database
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