NCT01428167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 2, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 6, 2012

Status Verified

June 1, 2012

Enrollment Period

11 months

First QC Date

August 10, 2011

Last Update Submit

June 5, 2012

Conditions

Thyroid CancerHashimotos Thyroiditis

Keywords

Thyroid cancerHashimotos thyroiditisThyroidectomyAnti-inflammatory factors

Outcome Measures

Primary Outcomes (1)

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

    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.

    one year

Secondary Outcomes (4)

  • Thyroid Ultrasound characteristics in participants with thyroid cancer in the setting of thyroid inflammation.

    one year

  • Prognostic factors of thyroid cancer

    one year

  • Complication of thyroidectomy( Thyroid surgery)

    2 weeks

  • Inflammatory factors level in Plasma sample

    one year

Study Arms (1)

Thyroidectomy

All patients undergoing thyroidectomy for a variety of indications.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • History of previous radiotherapy to head and neck and History of radioactive iodine therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch, Galveston , Endocrine Department

Galveston, Texas, 77555, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples with be stored to measure anti inflammatory factors.

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • LaDale St Clair, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2011

First Posted

September 2, 2011

Study Start

June 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 6, 2012

Record last verified: 2012-06

Locations

US(1)