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| ID | Type | Description | Link |
|---|---|---|---|
| R18HS029839 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Harvard School of Public Health (HSPH) | OTHER |
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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The investigators hypothesize that all-cause mortality in patients with an incidental thyroid nodule on PET-CT who did not have thyroid ultrasound (the exposure) within 3 months of the PET-CT is non-inferior within a 5% margin to those who have thyroid ultrasound at 7-years. That is, among patients with an incidental thyroid nodule on PET-CT, mortality is no more than 5% larger (in absolute difference) for those who do not have thyroid ultrasound compared to those who do. The investigators will also report mortality differences at landmark timeframes of 1-year, 3-years, 5-years, and 10-years. To estimate group differences in mortality, the investigators will conduct a non-inferiority emulated target trial utilizing clone-censor weighting to address potential immortal time bias introduced by the 3-month grace period. The investigators will adjust for demographic, potential confounder, and mortality risk adjustor factors. The investigators will stratify analyses based on baseline disease severity (estimated 5-year relative survival risk) and disease status (progression, lymph node involvement, other sites of metastases). All subjects will be accrued from the Mass General Brigham healthcare system, which includes two academic medical centers, a specialty head and neck hospital, and multiple community hospitals and numerous community clinics.
Study Hypothesis: The investigators hypothesize that all-cause mortality in patients with an incidental thyroid nodule on PET-CT who did not have thyroid ultrasound within 3 months is no worse than 5% lower than those who did have ultrasound.
Outcome Measures:
Primary Outcome: All-cause mortality. Secondary Outcomes: Numbers of thyroid cancer diagnoses, thyroid ultrasounds, thyroid biopsies, and thyroid surgeries Exploratory Outcomes: Types of thyroid cancer diagnoses
Study Population: All patients age 18-years and older with incidental thyroid nodule on PET-CT performed between 1/1/2015 and 12/31/2021.
Sites/Facilities: Mass General Brigham healthcare system including Massachusetts General Hospital, Brigham and Women's Hospital, Mass Eye and Ear, and associated community sites.
Exposure: Thyroid ultrasound evaluation within 3-months of PET-CT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with thyroid nodule on PET |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thyroid Ultrasound | Diagnostic Test | Thyroid ultrasound performed within 3 months of PET to characterize a thyroid nodule identified on the PET |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality | 7 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Thyroid Cancer Diagnoses | 7 Years | |
| Number of Thyroid Ultrasound Examinations | 7 Years | |
| Number of Thyroid Biopsies |
| Measure | Description | Time Frame |
|---|---|---|
| Types of Thyroid Cancers | Exploratory | 7 Years |
Inclusion Criteria:
Exclusion Criteria:
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Patients who had a PET-CT at Mass General Brigham 1/1/2015 to 12/31/2021
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
All deidentified data used in the study analysis.
Study protocol with study analysis plan submitted at time of clinicaltrials.gov registration. IPD and analytic code will be shared upon manuscript publication.
General public via the Harvard Dataverse repository.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: v1.0 | Nov 20, 2025 |
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| 7 Years |
| Number of Thyroid Surgeries | 7 Years |
| Nov 20, 2025 |
| Prot_SAP_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: v1.1 | Mar 15, 2026 | Mar 19, 2026 | Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D016606 | Thyroid Nodule |
| D004194 | Disease |
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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