Hashimotos Thyroiditis and Thyroid Cancer (Thyroid Cancer)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01428167 |
Recruitment Status :
Completed
First Posted : September 2, 2011
Last Update Posted : June 6, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Thyroid Cancer Hashimotos Thyroiditis |
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 : | Observational |
Actual Enrollment : | 26 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Is There Any Association Between Thyroid Cancer and Hashimotos Thyroiditis? |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |

Group/Cohort |
---|
Thyroidectomy
All patients undergoing thyroidectomy for a variety of indications.
|
- Number of Participants with thyroid cancer and Hashimoto's thyroiditis . [ Time Frame: one year ]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.
- Thyroid Ultrasound characteristics in participants with thyroid cancer in the setting of thyroid inflammation. [ Time Frame: one year ]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.
- Prognostic factors of thyroid cancer [ Time Frame: one year ]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.
- Complication of thyroidectomy( Thyroid surgery) [ Time Frame: 2 weeks ]Compare the complication of surgery in patients with thyroid cancer and Hashimoto's Thyroiditis and patients with thyroid cancer but without Hashimoto's thyroiditis.
- Inflammatory factors level in Plasma sample [ Time Frame: one year ]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.
Biospecimen Retention: Samples Without DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428167
United States, Texas | |
University of Texas Medical Branch, Galveston , Endocrine Department | |
Galveston, Texas, United States, 77555 |
Principal Investigator: | LaDale St Clair, MD | University of Texas |
Responsible Party: | The University of Texas Medical Branch, Galveston |
ClinicalTrials.gov Identifier: | NCT01428167 |
Other Study ID Numbers: |
11-112 |
First Posted: | September 2, 2011 Key Record Dates |
Last Update Posted: | June 6, 2012 |
Last Verified: | June 2012 |
Thyroid cancer Hashimotos thyroiditis Thyroidectomy Anti-inflammatory factors |
Thyroid Neoplasms Thyroid Diseases Thyroiditis Hashimoto Disease Endocrine System Diseases |
Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Thyroiditis, Autoimmune |