Thyroid CancerNCT00719615
Assess Vitamin D Levels in Those With & Without Thyroid Cancer
An observational study of Thyroid Cancer, run by University of Nebraska at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Thyroid Cancer
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2008to 1 Jun 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Pregnant or breast feeding women
- Medullary thyroid cancer
- Anaplastic thyroid cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: The Relationship Between Vitamin D and Thyroid Cancer
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.
Read the 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.
- Conditions
- Thyroid Cancer
- Keywords
- Thyroid Cancer, Thyroid Nodules, Vitamin D
- Medical subject headings
- Thyroid Neoplasms, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 months of enrollment in thyroid cancer collaborative registry (TCCR) database
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study start28 May 2008
- Primary completion1 Mar 2009
- Study completion1 Jun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathan W Laney, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719615
- Sponsor's protocol ID
- 0136-08-EP
- Status last verified
- Oct 2023
- First submitted
- 17 Jul 2008
- Last updated
- 16 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
National Cancer Institute 2006 Handbook, National Cancer Institute, Bethesda, MD. http://obf.cancer.gov/financial/attachments/06Factbk.pdf.
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.
PubMed 16380576Lappe 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.
PubMed 17556697Ahonen 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.
PubMed 11075874Abbas 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.
PubMed 17974532Krishnan 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.
PubMed 17229571Welsh 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.
PubMed 17723171Liu 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.
PubMed 11839571Dackiw 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.
PubMed 15319350Khadzkou 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.
PubMed 16314444
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Vitamin D and Thyroid Cancer
- ClinicalTrials.gov ID
- NCT00719615
- Acronym / sponsor ID
- 0136-08-EP
- Conditions
- Thyroid Cancer
- Keywords
- Thyroid Cancer, Thyroid Nodules, Vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 28 May 2008 (actual)
- Primary completion
- 1 Mar 2009 (actual)
- Study completion
- 1 Jun 2009 (actual)
- First posted
- 21 Jul 2008 (estimated)
- Results
- Posted 30 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnant or breast feeding women
- Medullary thyroid cancer
- Anaplastic thyroid cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundNational Cancer Institute 2006 Handbook, National Cancer Institute, Bethesda, MD. http://obf.cancer.gov/financial/attachments/06Factbk.pdf.
- Background: PubMed 16380576Garland 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.
- Background: PubMed 17556697Lappe 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.
- Background: PubMed 11075874Ahonen 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.
- Background: PubMed 17974532Abbas 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.
- Background: PubMed 17229571Krishnan 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.
- Background: PubMed 17723171Welsh 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.
- Background: PubMed 11839571Liu 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.
- Background: PubMed 15319350Dackiw 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.
- Background: PubMed 16314444Khadzkou 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.
- SEER Database.Link provided by the sponsor.
- National Cancer Institute 2006 Handbook, National Cancer Institute, Bethesda, MD. http://Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan W Laney, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00719615, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.