NCT05172921 · Icahn School of Medicine at Mount Sinai
Environmental Factors and Thyroid Cancer
What this study is about
Thyroid cancer incidence has been steadily increasing and has nearly tripled since the 1970's in the US and worldwide.
View original scientific description
Thyroid cancer incidence has been steadily increasing and has nearly tripled since the 1970's in the US and worldwide. Early detection of small, papillary thyroid cancers using high quality diagnostic imaging explains only about 50% of this increased incidence, suggesting that there is a true increase in the occurrence of thyroid cancer and that changes in the prevalence of environmental risk factors might play a role in thyroid cancer etiology and progression. Yet, the cascade of environmental triggers linked to thyroid cancer remains elusive. 'Exposomics' studies all health relevant chemical exposures that an individual experiences, and leverages metabolomic platforms to estimate the "internal" environment, informing both exogenous exposures and the metabolic products that lead to, or arise from, disease. Besides exposure to ionizing radiation as known modifiable risk factor, epidemiological evidence suggests that exposure to endocrine disrupting chemicals may be a potential thyroid cancer risk factor due to their known effects on thyroid function. However, these studies relied either on exposure questionnaires which are susceptible to recall bias, or used a limited set of targeted biomarkers measured after diagnosis for testing associations with case-control status, and not thyroid cancer prognosis. Further, the molecular basis for observed associations with thyroid cancer remains unclear. To address the overall hypothesis that environmental exposures alter metabolic pathways and therefore affect thyroid cancer prognosis, small amounts of blood will be collected using dried blood microsampler technology (e.g. Mitra® sampling devices), which is minimally invasive and can be used to collect repeated blood measurements at home, without the need for specialized training. These dried blood samples will be used to perform metabolomics experiments, which describe the sum of exogenous exposures, metabolic alterations, and biological response. Additional exposure assessment will be performed using an exposure questionnaire. These results will be associated with thyroid cancer prognosis, e.g. disease-specific survival, disease recurrence, and mutational profiles, thus investigating the role of environmental exposures in the development of more aggressive forms of thyroid cancer.
Primary outcome measures
Phospholipids
Time frame: 4 years
Using Liquid Chromatography-High Resolution MS (LC-HRMS) analysis, exposure profiles will be ascertain for existing of combination(s) of plasma metabolites (endogenous and exogenous) that act synergistically to increase risk of non-familial, papillary thyroid cancer. Phospholipids is an endogenous metabolite
Ceramides
Time frame: 4 years
Using Liquid Chromatography-High Resolution MS (LC-HRMS) analysis, exposure profiles will be ascertain for existing of combination(s) of plasma metabolites (endogenous and exogenous) that act synergistically to increase risk of non-familial, papillary thyroid cancer. Ceramides is an endogenous metabolite
per-and polyfluoroalkyl substances (PFAS)
Time frame: 4 years
Using Liquid Chromatography-High Resolution MS (LC-HRMS) analysis, exposure profiles will be ascertain for existing of combination(s) of plasma metabolites (endogenous and exogenous) that act synergistically to increase risk of non-familial, papillary thyroid cancer. per-and polyfluoroalkyl substances (PFAS) is an exogenous metabolite
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Bethesda category III, IV, V or VI following Fine Needle Aspiration; if a patient has a benign tumor following surgery, patient data/ samples will be stored to serve as benign control in potential future projects.
- Age 18 years and older
- Surgical candidate
- Ability to provide informed consent
Exclusion criteria
- History of thyroid cancer
- Completion surgery candidate
- Pregnant women or other vulnerable patients (e.g. wards of the state, prisoners)
Where
- New York, New York
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations