Clinical Study

Clinical Validation Of Thyroidprint: A Gene Expression Signature For Diagnosis Of Indeterminate Thyroid Nodules

Posted Date: Mar 21, 2018

  • Investigator: David Steward
  • Specialties:
  • Type of Study: Observational/Survey

Thyroid nodules are a very frequent condition affecting about 1 out of 3 adults. In many cases, a fine needle aspiration (FNA) biopsy is performed to determine the nature of the thyroid nodule. Some FNA biopsies of thyroid nodules are reported as indeterminate which means the results are unknown or uncertain. An indeterminate result means that the nodule cannot be classified as cancerous or noncancerous. In many cases, an indeterminate result will lead doctors to recommend surgery to determine the true nature of a thyroid nodule. About 15 – 30 out of 100 times the indeterminate thyroid nodule is cancerous. The purpose of this study is to evaluate the performance of an investigational test that measures several genes in indeterminate FNA biopsy samples and identifies the cases that are noncancerous. Measuring these genes may improve our ability to better determine that true nature of a thyroid nodule. In the future, this test could help patients with indeterminate thyroid nodules to avoid surgery. The results of the testing will not be given to you, your doctor, or the study doctor.


You Are Being Asked To Take Part In This Research Study Because You Having A Fine Needle Aspiration (Fna) Biopsy To Determine The Nature Of Your Thyroid Nodule(S). Or, You Will Be Undergoing Surgery Of Your Thyroid Gland Because You Have Previous Results Of An Fna Reported As Indeterminate. If You Are Willing To Participate, You Must Sign This Informed Consent Form Giving Permission To Have Additional Samples Collected For Testing At The Same Time Your Standard Of Care Fna Biopsy Sample Is Collected, Or The Fna Samples Will Be Collected From Your Thyroid When You Are Asleep At The Time Of Your Surgery. By Signing This Informed Consent Form, You Also Give Permission To Have Your Medical Records Reviewed And Gene Analysis Performed On Your Additional Sample Based On The Results Of Your Fna.


Thyroid Nodule , Fine Needle Aspiration, Thyroid Gland , Null, Null

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Becky Reinert