Thyroid CancerNCT05172921
Environmental Factors and Thyroid Cancer
An observational study of Thyroid Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2022to Jun 2035
- How long will I take part?
- 4 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Thyroid cancer patients seen within the Mount Sinai Health System
Who may be able to join
- 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
Who cannot join
- History of thyroid cancer
- Completion surgery candidate
- Pregnant women or other vulnerable patients (e.g. wards of the state, prisoners)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Mathilda Alsen, MPH, 212-659-1531 ext. 1513, mathilda.alsen@mountsinai.org
Maaike van Gerwen
About this study
Official title: The Role of Environmental Factors in 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.
- Conditions
- Thyroid Cancer
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed | High exposure to environmental pollutants | |
| Non-exposed | Low exposure to environmental pollutants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phospholipids
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
Measured: 4 years
Ceramides
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
Measured: 4 years
per-and polyfluoroalkyl substances (PFAS)
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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start3 Feb 2022
- Primary completionJun 2030 (estimated)
- Study completionJun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maaike A Van Gerwen, Icahn School of Medicine at Mount Sinai
- Investigators
- Maaike van Gerwen, MD, PhD, Principal investigator, MSH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172921
- Sponsor's protocol ID
- STUDY-21-01547
- Status last verified
- Jun 2026
- First submitted
- 23 Dec 2021
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to make IPD available to other researchers. Researchers will have access to the data/ samples in a de-identified manner.