Environmental Factors and Thyroid Cancer

NCT ID: NCT05172921

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-03
• Study Completion Date: 2035-09-30

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 Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Exposed

High exposure to environmental pollutants

No interventions assigned to this group

Non-exposed

Low exposure to environmental pollutants

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Maaike A Van Gerwen

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maaike van Gerwen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

MSH

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maaike van Gerwen, MD, PhD

Role: CONTACT

maaike.vangerwen@mountsinai.org

2126599620

Facility Contacts

Mathilda Alsen, MPH

Role: primary

mathilda.alsen@mountsinai.org

212-659-1531 ext. 1513

Other Identifiers

STUDY-21-01547

Identifier Type: -

Identifier Source: org_study_id