Gland and Hormone Related Diseases

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Neoplasms

Thyroid Diseases

Thyroid Nodule

Endocrine System Diseases

Thyroid Neoplasms

Endocrine Gland Neoplasms

Head and Neck Neoplasms

single molecular test GEC of collected tissue

single molecular test ThyroSeq v.2 of collected tissue

single molecular test GSC of collected tissue

single molecular test ThyroSeq v.3 of collected tissue

Afirma GEC molecular test on collected thyroid tissue

Afirma GEC

ThyroSeq v.2 molecular test on collected thyroid tissue

ThyroSeq v.2

Afirma GSC molecular test on collected thyroid tissue

Afirma GSC

ThyroSeq v.3 molecular test on collected thyroid tissue

ThyroSeq v.3

Masha Livhits, MC

The purpose of this study is to compare the performance of Afirma GSC and ThyroSeq v.3 in indeterminate thyroid nodules to determine which test can allow more patients to avoid unnecessary surgery and preserve quality of life. In the initial phase of this study, the performance of Afirma GEC and ThyroSeq v.2 were compared.

1. All patients undergoing thyroid FNA within the UCLA Health System will be randomized at the time of FNA to a single molecular test (GSC or ThyroSeq v.3). In the previous phase of the study, patients were randomized to the previous versions of a single molecular test (GEC or ThyroSeq v.2).
2. During the FNA, a sample will be collected for the molecular test.
3. If the cytology results are indeterminate (Bethesda categories 3 or 4), the molecular test will be reflexively sent off.
4. We will help patients with indeterminate thyroid nodules to establish care with an endocrinologist, if they do not already have one. The physicians will make treatment recommendations using best practices and incorporating the results of the molecular test. We anticipate that most patients with a positive molecular test will undergo surgery, while the majority with a negative test will be surveiled.
5. Patients who undergo surgery will have histopathologic evaluation of the thyroid, which will determine whether the index thyroid nodule was benign or malignant.
6. Patients who do not undergo surgery will have a followup ultrasound at 6 and 12 months, or sooner at the discretion of the treating physician.
7. We will assess thyroid-specific quality of life at baseline (following initial diagnosis of an indeterminate thyroid nodule) and during followup (at 6 and 12 months) using the short version of Thyroid-Related Patient-Reported Outcome.

Randomized Trial Comparing Performance of Molecular Markers for Indeterminate Thyroid Nodules

compare the performance of Afirma GEC and ThyroSeq v.2 in indeterminate thyroid nodules to determine which test can allow more patients to avoid unnecessary surgery and preserve quality of life. (5) Patients who undergo surgery will have histopathologic evaluation of the thyroid, which will determine whether the index thyroid nodule was benign or malignant.

compare the performance of Afirma GSC and ThyroSeq v.3 in indeterminate thyroid nodules to determine which test can allow more patients to avoid unnecessary surgery and preserve quality of life. (5) Patients who undergo surgery will have histopathologic evaluation of the thyroid, which will determine whether the index thyroid nodule was benign or malignant.

Determine the number of unnecessary surgeries avoided based on the number of false-positive test results, and assess whether this translated into improved quality of life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Randomized Trial Comparing Performance of Molecular Markers for Indeterminate Thyroid Nodules	NCT02681328	Thyroid	Afirma GEC ThyroSeq v.2 Afirma GSC ThyroSeq v.3	18 Years - 100 Years	Jonsson Comprehensive Cancer Center
Randomized Trial Comparing Performance of Molecular Markers for Indeterminate Thyroid Nodules	NCT02681328	Thyroid	Afirma GEC ThyroSeq v.2 Afirma GSC ThyroSeq v.3	18 Years - 100 Years	Jonsson Comprehensive Cancer Center

Spots Global Cancer Trial Database for afirma gsc

Every month we try and update this database with for afirma gsc cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for afirma gsc

Every month we try and update this database with for afirma gsc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for afirma gsc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.