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Is There Any Association Between Thyroid Cancer and Hashimotos Thyroiditis?


N/A
18 Years
80 Years
Not Enrolling
Both
Thyroid Cancer, Hashimotos Thyroiditis

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Trial Information

Is There Any Association Between Thyroid Cancer and 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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Number of Participants with thyroid cancer and Hashimoto's thyroiditis .

Outcome Description:

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.

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

LaDale St Clair, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas

Authority:

United States: Institutional Review Board

Study ID:

11-112

NCT ID:

NCT01428167

Start Date:

June 2011

Completion Date:

May 2012

Related Keywords:

  • Thyroid Cancer
  • Hashimotos Thyroiditis
  • Thyroid cancer
  • Hashimotos thyroiditis
  • Thyroidectomy
  • Anti-inflammatory factors
  • Thyroid Neoplasms
  • Thyroid Diseases
  • Thyroiditis
  • Hashimoto Disease

Name

Location

University of Texas Medical Branch, Galveston , Endocrine DepartmentGalveston, Texas  77555