Role of Endocrine Disruptors in Thyroid Cancer

Thyroid Cancer Clinical Trial

— THY-ED  

Official title:

Cross-sectional Case-control Study on the Role of Endocrine Disruptors in Thyroid Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05747365
• Other study ID #: 05C214
• Status: Recruiting
• Start date: July 12, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2024
• Source: Istituto Auxologico Italiano
• Contact: Laura Fugazzola, MD
• Phone: +390261911
• Email: l.fugazzola[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

the relationship between human exposure to EDCS and TC is poorly investigated and still unclear. The aim of this study is to evaluate the possible role of old and new generation endocrine disruptors in thyroid cancer. The primary aim is to evaluate the difference in the average levels of the main endocrine disruptors (PFAS, including: PFOA, PFOS, PFDA, PFUnA, PFHpS and possibly subsequently other categories, such as bisphenols, phthalates, parabens, PCBs, flame retardants) between patients with and without a diagnosis of thyroid cancer through highly sensitive, selective and precise mass spectrometry methods, such as liquid chromatography combined with tandem mass spectrometry (LC-MS / MS).

The secondary aim is to evaluate the relationship between the concentrations of endocrine disruptors and some anamnestic variables studied (for example the type of diet, the use of personal care products).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 222
• Est. completion date: July 31, 2025
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with a diagnosis of thyroid cancer in the last 5 years (arm A)

• patients without a diagnosis of thyroid cancer will match patients included in arm A

Exclusion Criteria:

• subjects under 18 years old

• patients unable to sign the informed consent or questionnaires

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Diagnostic Test:
• Blood and urine diagnostic evaluation
Blood and urine samples will be obtained from both case and control groups in order to evaluate EDCs concentrations

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano, IRCCS	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the average levels of the main endocrine disruptors	The main endocrine disruptors evaluated will be PFAS, including: PFOA, PFOS, PFDA, PFUnA, PFHpS and possibly subsequently other categories, such as bisphenols, phthalates, parabens, PCBs, flame retardants	At recruitment
Primary	Relationship between the concentrations of endocrine disruptors and anamnestic variables	Relationship between the concentrations of endocrine disruptors and some anamnestic variables studied (for example the type of diet, the use of personal care products).	At recruitment