Randomized Trial Comparing Performance of Molecular Markers for Indeterminate Thyroid Nodules

Active, not recruiting

• Conditions: Thyroid
• Interventions: Other: ThyroSeq v.3; Other: Afirma GSC; Other: Afirma GEC; Other: ThyroSeq v.2

• Registration Number: NCT02681328
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-12
• Study Start: 2016-05-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 328

Inclusion Criteria

• Patients with a thyroid nodule who have a thyroid biopsy performed at UCLA health will be eligible for the study and consented if they agree to participate.
• Patients who have an indeterminate FNA biopsy result (Bethesda category 3 or 4) will be enrolled in the study if they agree to participate.

Exclusion Criteria

• Patients who do not have an indeterminate biopsy result (either patients who have a benign, insufficient, or malignant result).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ThyroSeq v.3	ThyroSeq v.3	single molecular test ThyroSeq v.3 of collected tissue
Afirma GSC	Afirma GSC	single molecular test GSC of collected tissue
Afirma GEC	Afirma GEC	single molecular test GEC of collected tissue
ThyroSeq v.2	ThyroSeq v.2	single molecular test ThyroSeq v.2 of collected tissue

Primary Outcome Measures

Name	Time	Method
Afirma GEC vs. ThyroSeq v.2 in indeterminate thyroid nodules post best practices surgery	12 months. [This phase of the study is now completed]	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.
2. Afirma GSC vs. ThyroSeq v.3 in indeterminate thyroid nodules post best practices surgery	12 months.	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.

Secondary Outcome Measures

Name	Time	Method
Avoidance of unnecessary surgeries	12 months	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.

Trial Locations

Locations (1)

Jonsson Comprehensive Cancer Center at UCLA; 🇺🇸 Los Angeles, California, United States