Randomized Trial Comparing Performance of Molecular Markers for Indeterminate Thyroid Nodules

NCT02681328 | Active Not Recruiting

• 1 other identifier: 16-000055
• Study Type: observational
• Target: 328
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid

Outcome Measures

Primary Outcomes (2)

• Afirma GEC vs. ThyroSeq v.2 in indeterminate thyroid nodules post best practices surgery

  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.

  12 months. [This phase of the study is now completed]

• 2. Afirma GSC vs. ThyroSeq v.3 in indeterminate thyroid nodules post best practices surgery

  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.

  12 months.

Secondary Outcomes (1)

• Avoidance of unnecessary surgeries

  12 months

Study Arms (4)

Afirma GEC

single molecular test GEC of collected tissue

Other: Afirma GEC

ThyroSeq v.2

single molecular test ThyroSeq v.2 of collected tissue

Other: ThyroSeq v.2

Afirma GSC

single molecular test GSC of collected tissue

Other: Afirma GSC

ThyroSeq v.3

single molecular test ThyroSeq v.3 of collected tissue

Other: ThyroSeq v.3

Interventions

Afirma GEC OTHER

Afirma GEC molecular test on collected thyroid tissue

Afirma GEC

ThyroSeq v.2 OTHER

ThyroSeq v.2 molecular test on collected thyroid tissue

ThyroSeq v.2

Afirma GSC OTHER

Afirma GSC molecular test on collected thyroid tissue

Afirma GSC

ThyroSeq v.3 OTHER

ThyroSeq v.3 molecular test on collected thyroid tissue

ThyroSeq v.3

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing thyroid fine needle aspiration (FNA) within the University of California, Los Angeles (UCLA) Health System

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Related Publications (10)

• Cibas ES, Ali SZ; NCI Thyroid FNA State of the Science Conference. The Bethesda System For Reporting Thyroid Cytopathology. Am J Clin Pathol. 2009 Nov;132(5):658-65. doi: 10.1309/AJCPPHLWMI3JV4LA.

  PMID: 19846805 BACKGROUND

• Lee L, How J, Tabah RJ, Mitmaker EJ. Cost-effectiveness of molecular testing for thyroid nodules with atypia of undetermined significance cytology. J Clin Endocrinol Metab. 2014 Aug;99(8):2674-82. doi: 10.1210/jc.2014-1219. Epub 2014 Mar 31.

  PMID: 24684467 BACKGROUND

• Alexander EK, Kennedy GC, Baloch ZW, Cibas ES, Chudova D, Diggans J, Friedman L, Kloos RT, LiVolsi VA, Mandel SJ, Raab SS, Rosai J, Steward DL, Walsh PS, Wilde JI, Zeiger MA, Lanman RB, Haugen BR. Preoperative diagnosis of benign thyroid nodules with indeterminate cytology. N Engl J Med. 2012 Aug 23;367(8):705-15. doi: 10.1056/NEJMoa1203208. Epub 2012 Jun 25.

  PMID: 22731672 BACKGROUND

• Nikiforov YE, Carty SE, Chiosea SI, Coyne C, Duvvuri U, Ferris RL, Gooding WE, LeBeau SO, Ohori NP, Seethala RR, Tublin ME, Yip L, Nikiforova MN. Impact of the Multi-Gene ThyroSeq Next-Generation Sequencing Assay on Cancer Diagnosis in Thyroid Nodules with Atypia of Undetermined Significance/Follicular Lesion of Undetermined Significance Cytology. Thyroid. 2015 Nov;25(11):1217-23. doi: 10.1089/thy.2015.0305. Epub 2015 Sep 10.

  PMID: 26356635 BACKGROUND

• Wu JX, Lam R, Levin M, Rao J, Sullivan PS, Yeh MW. Effect of malignancy rates on cost-effectiveness of routine gene expression classifier testing for indeterminate thyroid nodules. Surgery. 2016 Jan;159(1):118-26. doi: 10.1016/j.surg.2015.05.035. Epub 2015 Oct 2.

  PMID: 26435428 BACKGROUND

• Wu JX, Young S, Hung ML, Li N, Yang SE, Cheung DS, Yeh MW, Livhits MJ. Clinical Factors Influencing the Performance of Gene Expression Classifier Testing in Indeterminate Thyroid Nodules. Thyroid. 2016 Jul;26(7):916-22. doi: 10.1089/thy.2015.0505. Epub 2016 Jun 9.

  PMID: 27161519 BACKGROUND

• Hu TX, Nguyen DT, Patel M, Beckett K, Douek M, Masamed R, Rhyu J, Kim J, Tseng CH, Yeh MW, Livhits MJ. The Effect Modification of Ultrasound Risk Classification on Molecular Testing in Predicting the Risk of Malignancy in Cytologically Indeterminate Thyroid Nodules. Thyroid. 2022 Aug;32(8):905-916. doi: 10.1089/thy.2021.0659. Epub 2022 Jun 23.

  PMID: 35611970 DERIVED

• Zhu CY, Donangelo I, Gupta D, Nguyen DT, Ochoa JE, Yeh MW, Livhits MJ. Outcomes of Indeterminate Thyroid Nodules Managed Nonoperatively after Molecular Testing. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1240-e1247. doi: 10.1210/clinem/dgaa887.

  PMID: 33394039 DERIVED

• Livhits MJ, Zhu CY, Kuo EJ, Nguyen DT, Kim J, Tseng CH, Leung AM, Rao J, Levin M, Douek ML, Beckett KR, Cheung DS, Gofnung YA, Smooke-Praw S, Yeh MW. Effectiveness of Molecular Testing Techniques for Diagnosis of Indeterminate Thyroid Nodules: A Randomized Clinical Trial. JAMA Oncol. 2021 Jan 1;7(1):70-77. doi: 10.1001/jamaoncol.2020.5935.

  PMID: 33300952 DERIVED

• Livhits MJ, Kuo EJ, Leung AM, Rao J, Levin M, Douek ML, Beckett KR, Zanocco KA, Cheung DS, Gofnung YA, Smooke-Praw S, Yeh MW. Gene Expression Classifier vs Targeted Next-Generation Sequencing in the Management of Indeterminate Thyroid Nodules. J Clin Endocrinol Metab. 2018 Jun 1;103(6):2261-2268. doi: 10.1210/jc.2017-02754.

  PMID: 29590358 DERIVED

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Masha Livhits, MC

  Visiting Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 12, 2016
• Study Start: May 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)