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Randomized Trial Comparing Performance of Molecular Markers for Indeterminate Thyroid Nodules

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ClinicalTrials.gov Identifier: NCT02681328
Recruitment Status : Recruiting
First Posted : February 12, 2016
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Thyroid Other: Afirma GEC Other: ThyroSeq v.2 Other: Afirma GSC Other: ThyroSeq v.3

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Randomized Trial Comparing Performance of Molecular Markers for Indeterminate Thyroid Nodules
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Group/Cohort Intervention/treatment
Afirma GEC
single molecular test GEC of collected tissue
Other: Afirma GEC
Afirma GEC molecular test on collected thyroid tissue

ThyroSeq v.2
single molecular test ThyroSeq v.2 of collected tissue
Other: ThyroSeq v.2
ThyroSeq v.2 molecular test on collected thyroid tissue

Afirma GSC
single molecular test GSC of collected tissue
Other: Afirma GSC
Afirma GSC molecular test on collected thyroid tissue

ThyroSeq v.3
single molecular test ThyroSeq v.3 of collected tissue
Other: ThyroSeq v.3
ThyroSeq v.3 molecular test on collected thyroid tissue




Primary Outcome Measures :
  1. Afirma GEC vs. ThyroSeq v.2 in indeterminate thyroid nodules post best practices surgery [ Time Frame: 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. 2. Afirma GSC vs. ThyroSeq v.3 in indeterminate thyroid nodules post best practices surgery [ Time Frame: 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 :
  1. Avoidance of unnecessary surgeries [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing thyroid fine needle aspiration (FNA) within the University of California, Los Angeles (UCLA) Health System
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02681328


Contacts
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Contact: Masha Livhits, MD 310-206-2781 mlivhits@mednet.ucla.edu

Locations
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United States, California
Jonsson Comprehensive Cancer Center at UCLA Recruiting
Los Angeles, California, United States, 90095-1781
Contact: Masha Livhits, MD    310-206-2781    mlivhits@mednet.ucla.edu   
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Masha Livhits, MC Visiting Assistant Professor
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02681328    
Other Study ID Numbers: 16-000055
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thyroid Nodule
Thyroid Diseases
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms