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Hashimotos Thyroiditis and Thyroid Cancer (Thyroid Cancer)

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ClinicalTrials.gov Identifier: NCT01428167
Recruitment Status : Completed
First Posted : September 2, 2011
Last Update Posted : June 6, 2012
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Tracking Information
First Submitted Date August 10, 2011
First Posted Date September 2, 2011
Last Update Posted Date June 6, 2012
Study Start Date June 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 1, 2011)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 6, 2011)
  • 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.
Original Secondary Outcome Measures
 (submitted: September 1, 2011)
  • Thyroid U/S 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hashimotos Thyroiditis and Thyroid Cancer
Official Title Is There Any Association Between Thyroid Cancer and Hashimotos Thyroiditis?
Brief Summary Thyroid cancer (TC) is the most common endocrine malignancy. The association between inflammation and cancer is well established but the association between thyroiditis (inflammation of thyroid gland) especially Hashimoto's thyroiditis (HT) and thyroid cancer remains controversial. Chronic inflammation leads to a repeated cycle of cellular damage and subsequent healing which contributes to inappropriate cell proliferation and subsequent neoplastic transformation. One of the most common forms of Thyroiditis is Hashimoto's thyroiditis which is a chronic autoimmune inflammatory disease affects almost 5% of the population and is more common in women. For the first time, Dailey and Lindsay reported in 1955 an increased association between Hashimoto's Thyroiditis (HT) and thyroid cancer. They reported 35 thyroid cancers in 278 patients with Hashimoto's Thyroiditis, a prevalence of 17.7% which they considered higher than the general population . Since then, various studies have been done, some studies have reported an increased risk of malignancy in Hashimoto's thyroiditis; others have failed to find an association. Most of the studies that have been done to identify the association between Hashimoto's thyroiditis and thyroid cancer are retrospective. The purpose of this pilot case-control study is to identify the association of Hashimoto's thyroiditis and thyroid cancer, to determine if the presence of Hashimoto's thyroiditis has any affect on the complication of thyroidectomy and prognostic factors of thyroid cancer.
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 Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma samples with be stored to measure anti inflammatory factors.
Sampling Method Non-Probability Sample
Study Population All patients undergoing thyroidectomy for a variety of indications at University of Texas Medical Branch in Galveston between June 2011-May 2012
Condition
  • Thyroid Cancer
  • Hashimotos Thyroiditis
Intervention Not Provided
Study Groups/Cohorts Thyroidectomy
All patients undergoing thyroidectomy for a variety of indications.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 5, 2012)
26
Original Estimated Enrollment
 (submitted: September 1, 2011)
40
Actual Study Completion Date May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01428167
Other Study ID Numbers 11-112
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party The University of Texas Medical Branch, Galveston
Study Sponsor The University of Texas Medical Branch, Galveston
Collaborators Not Provided
Investigators
Principal Investigator: LaDale St Clair, MD University of Texas
PRS Account The University of Texas Medical Branch, Galveston
Verification Date June 2012