THY-ED: Role of Endocrine Disruptors in Thyroid Cancer

Sponsor
Istituto Auxologico Italiano (Other)
Overall Status
Recruiting
CT.gov ID
NCT05747365
Collaborator
(none)
222
1
36.6
6.1

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Blood and urine diagnostic evaluation

Study Design

Study Type:
Observational
Anticipated Enrollment :
222 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Cross-sectional Case-control Study on the Role of Endocrine Disruptors in Thyroid Cancer
Actual Study Start Date :
Jul 12, 2022
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Case group

Patients with thyroid cancer diagnosis within 5 years before study enrollment

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

Control group

Patients without clinical diagnosis of thyroid disease

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

Outcome Measures

Primary Outcome Measures

  1. Difference in the average levels of the main endocrine disruptors [At recruitment]

    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

  2. Relationship between the concentrations of endocrine disruptors and anamnestic variables [At recruitment]

    Relationship between the concentrations of endocrine disruptors and some anamnestic variables studied (for example the type of diet, the use of personal care products).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istituto Auxologico Italiano, IRCCS Milan Italy 20149

Sponsors and Collaborators

  • Istituto Auxologico Italiano

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istituto Auxologico Italiano
ClinicalTrials.gov Identifier:
NCT05747365
Other Study ID Numbers:
  • 05C214
First Posted:
Feb 28, 2023
Last Update Posted:
Mar 2, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2023