Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05172921

Environmental Factors and Thyroid Cancer

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Location status: Recruiting

Location contact

Maaike van Gerwen

PRINCIPAL_INVESTIGATOR

Mathilda Alsen, MPH

CONTACT

[email protected]

212-659-1531 ext. 1513

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Maaike van Gerwen, MD, PhD

CONTACT

[email protected]

2126599620

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

The Role of Environmental Factors in Thyroid Cancer

Important dates

Study start
2022
Primary completion
2030
Study completion
2035
First posted
Dec 29, 2021
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.