Thyroid Cancer
Conditions
Keywords
Thyroid Cancer, Thyroid Nodules, Vitamin D
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.
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.
Interventions
None listed
Sponsors
University of Nebraska
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Persons That Are Vitamin D Deficient in the Thyroid Nodule, Thyroid Cancer in Remission, and the Active Thyroid Cancer Groups. | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Individuals who had agreed to participate in the TCCR and who had also given a blood sample were included in sequential order.
Participants by arm
| Arm | Count |
|---|---|
| Thyroid Nodules | 42 |
| Thyroid Cancer in Remission | 45 |
| Active Thyroid Cancer | 24 |
| Total | 111 |
Baseline characteristics
| Characteristic | Thyroid Nodules | Thyroid Cancer in Remission | Active Thyroid Cancer | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 44 Participants | 22 Participants | 106 Participants |
| Region of Enrollment United States | 42 participants | 45 participants | 24 participants | 111 participants |
| Sex: Female, Male Female | 38 Participants | 39 Participants | 17 Participants | 94 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 7 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 42 | 0 / 45 | 0 / 24 |
| serious Total, serious adverse events | 0 / 42 | 0 / 45 | 0 / 24 |
Outcome results
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.
Time frame: Within 12 months of enrollment in thyroid cancer collaborative registry (TCCR) database
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thyroid Nodules | Number of Persons That Are Vitamin D Deficient in the Thyroid Nodule, Thyroid Cancer in Remission, and the Active Thyroid Cancer Groups. | 23 participants |
| Thyroid Cancer in Remission | Number of Persons That Are Vitamin D Deficient in the Thyroid Nodule, Thyroid Cancer in Remission, and the Active Thyroid Cancer Groups. | 20 participants |
| Active Thyroid Cancer | Number of Persons That Are Vitamin D Deficient in the Thyroid Nodule, Thyroid Cancer in Remission, and the Active Thyroid Cancer Groups. | 11 participants |
Comparison: Patient characteristics for each group were assessed using descriptive statistics, including medians, range, frequencies, and proportions. Categorical outcomes were compared between the 3 groups using a Fisher's exact test. A logistic regression modeling procedure was used to compare the odds of a low vitamin D levels between patient groups while adjusting for other risk factors: gender, age, BMI, season, and TNM staging.p-value: <0.05Fisher Exact