Recruiting

Observational Study

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05172921

Conditions

Thyroid Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Thyroid Cancer

Study ID

NCT05172921

Start date

Feb 3, 2022

Status verified date

Jun, 2026

Completion date

Jun, 2035

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Exposed

High exposure to environmental pollutants

Non-exposed

Low exposure to environmental pollutants

Primary outcome measure

  • Phospholipids [ Time Frame: 4 years ]
  • Ceramides [ Time Frame: 4 years ]
  • per-and polyfluoroalkyl substances (PFAS) [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Maaike van Gerwen

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-06-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.