Skip to main content
OpenTrials
Completed

NCT Number: NCT01428167

Hashimotos Thyroiditis and Thyroid Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Hashimotos Thyroiditis Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Medical Branch, Galveston , Endocrine Department

Galveston, Texas, 77555, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

Is There Any Association Between Thyroid Cancer and Hashimotos Thyroiditis?

Acronym: Thyroid Cancer

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 2, 2011
Registry last updated
Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.