- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01428167
Hashimotos Thyroiditis and Thyroid Cancer (Thyroid Cancer)
Is There Any Association Between Thyroid Cancer and Hashimotos Thyroiditis?
Study Overview
Status
Conditions
Detailed Description
AIM1: To identify the association between Hashimoto's Thyroiditis and thyroid cancer by comparing the prevalence of thyroid cancer in patients with Hashimoto's Thyroiditis and patients without Hashimoto's Thyroiditis who undergoing Thyroidectomy for a variety of indications in UTMB in 12 months period of the study.
AIM2: Compare Ultrasound (US) characteristics preoperatively in two groups of patients with thyroid cancer and Hashimoto's thyroiditis and patients with thyroid cancer but without Hashimoto's thyroiditis.
AIM3: compare prognostic factors including tumor diameter, vascular and capsular invasion, extra thyroid invasion, lymph node metastasis, distant metastasis in two groups of patients including patients with thyroid cancer and Hashimoto's thyroiditis and patients with thyroid cancer but without Hashimoto's thyroiditis.
AIM4: Compare the complication of surgery in patients with thyroid cancer and Hashimoto's Thyroiditis and patients with thyroid cancer but without Hashimoto's thyroiditis.
AIM5: Compare inflammatory factors in two group of patient with thyroid cancer and Hashimoto's Thyroiditis and patients with thyroid cancer but without Hashimoto's thyroiditis.
Coordinator in the ear, nose and throat (ENT) clinic will notify the assigned investigator about any patient admitted to UTMB for thyroidectomy. The investigator will meet and interview the patient to obtain the consent and fill out a data collection sheet which will include demographic data, history of thyroid disease, history of thyroid medications, history of radiotherapy of head and neck or radioactive iodine therapy, family history of thyroid disease or thyroid cancer. Patients meeting the inclusion criteria will be given the opportunity to participate in the study. All patients will have blood drawn. Blood samples will be stored in Endocrinology lab to measure Anti-TPO, Ca, PTH and inflammatory factors at the end of study. A chart review of all enrolled patients will be performed to obtain details of the preoperative thyroid U/S characteristics including echogenicity, texture, calcification, vascularity and TSH and Free T4 level. Postoperative histopathology evaluation will be done by a pathologist experienced in thyroid pathology. The diagnosis of Hashimoto's thyroiditis (HT ) will be made based on histopathology finding and AntiTPO level. The histopathology criteria for Hashimoto's thyroiditis (HT) must be seen in a normal region of the thyroid gland, distinct from the site of thyroid cancer. UTMB Subjects will be divided to two groups, subjects with Hashimoto's Thyroiditis and subjects without Hashimoto's Thyroiditis (control group).The prevalence of thyroid cancer will be compared in these two groups.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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Galveston, Texas, United States, 77555
- University of Texas Medical Branch, Galveston , Endocrine Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients undergoing thyroidectomy for a variety of indications at University of Texas Medical Branch in Galveston between June 2011-May 2012
- Age 18-80 years old
Exclusion Criteria:
History of previous radiotherapy to head and neck and History of radioactive iodine therapy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Thyroidectomy
All patients undergoing thyroidectomy for a variety of indications.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with thyroid cancer and Hashimoto's thyroiditis .
Time Frame: one year
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To identify the association between Hashimoto's Thyroiditis and thyroid cancer by comparing the prevalence of thyroid cancer in patients with Hashimoto's Thyroiditis and patients without Hashimoto's Thyroiditis who undergoing Thyroidectomy for a variety of indications in UTMB in 12 months period of the study.
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one year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thyroid Ultrasound characteristics in participants with thyroid cancer in the setting of thyroid inflammation.
Time Frame: one year
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Compare Ultrasound (US) characteristics preoperatively in two groups of patients with thyroid cancer and Hashimoto's thyroiditis and patients with thyroid cancer but without Hashimoto's thyroiditis.
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one year
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Prognostic factors of thyroid cancer
Time Frame: one year
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compare prognostic factors including tumor diameter, vascular and capsular invasion, extra thyroid invasion, lymph node metastasis, distant metastasis in two groups of patients including patients with thyroid cancer and Hashimoto's thyroiditis and patients with thyroid cancer but without Hashimoto's thyroiditis.
|
one year
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Complication of thyroidectomy( Thyroid surgery)
Time Frame: 2 weeks
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Compare the complication of surgery in patients with thyroid cancer and Hashimoto's Thyroiditis and patients with thyroid cancer but without Hashimoto's thyroiditis.
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2 weeks
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Inflammatory factors level in Plasma sample
Time Frame: one year
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Compare inflammatory factors in two group of patient with thyroid cancer and Hashimoto's Thyroiditis and patients with thyroid cancer but without Hashimoto's thyroiditis.
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one year
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Collaborators and Investigators
Investigators
- Principal Investigator: LaDale St Clair, MD, University of Texas
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-112
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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