NCT00719615

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 30, 2010

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

July 17, 2008

Results QC Date

January 27, 2010

Last Update Submit

October 2, 2023

Conditions

Thyroid Cancer

Keywords

Thyroid CancerThyroid NodulesVitamin D

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant or breast feeding women
  • Medullary thyroid cancer
  • Anaplastic thyroid cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (10)

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

    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.

    PMID: 16380576BACKGROUND

  • 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.

    PMID: 17556697BACKGROUND

  • 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.

    PMID: 11075874BACKGROUND

  • 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.

    PMID: 17974532BACKGROUND

  • 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.

    PMID: 17229571BACKGROUND

  • 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.

    PMID: 17723171BACKGROUND

  • 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.

    PMID: 11839571BACKGROUND

  • 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.

    PMID: 15319350BACKGROUND

  • 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.

    PMID: 16314444BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood.

MeSH Terms

Conditions

Thyroid NeoplasmsThyroid Nodule

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Limitations and Caveats

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.

Results Point of Contact

Title
Whitney S Goldner, MD
Organization
University of Nebraska Medical Center
wgoldner@unmc.edu
402-559-6205

Study Officials

  • Nathan W Laney, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 21, 2008

Study Start

May 28, 2008

Primary Completion

March 1, 2009

Study Completion

June 1, 2009

Last Updated

October 16, 2023

Results First Posted

March 30, 2010

Record last verified: 2023-10

Locations

US(1)