Endocrine Disruptor ChemicalsTHY-EDNCT05747365
Role of Endocrine Disruptors in Thyroid Cancer
An observational study of Endocrine Disruptor Chemicals and Thyroid Cancer, run by Istituto Auxologico Italiano at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocrine Disruptor Chemicals, Thyroid Cancer
- What is being tested?
- Blood and urine diagnostic evaluation
- How many people
- 222 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jul 2022to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: all patients referred to our tertiary clinical center for thyroid cancer diagnosed in the last 5 years will be consecutively enrolled (case population). Patients without a diagnosis of thyroid cancer will match patients included in the case population, according to age and sex.
Who may be able to join
- 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
Who cannot join
- subjects under 18 years old
- patients unable to sign the informed consent or questionnaires
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano, IRCCS
Milan, 20149
Laura Fugazzola, MD, +390261911 ext. 2727, l.fugazzola@auxologico.it
About this study
Official title: Cross-sectional Case-control Study on the Role of Endocrine Disruptors in Thyroid Cancer
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).
- Conditions
- Endocrine Disruptor Chemicals, Thyroid Cancer
- Being tested
- Blood and urine diagnostic evaluation
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and urine diagnostic evaluationDiagnostic test
Blood and urine samples will be obtained from both case and control groups in order to evaluate EDCs concentrations
| Study group | Role | What they receive |
|---|---|---|
| Case group | Patients with thyroid cancer diagnosis within 5 years before study enrollment Receives: Diagnostic Test: Blood and urine diagnostic evaluation | |
| Control group | Patients without clinical diagnosis of thyroid disease Receives: Diagnostic Test: Blood and urine diagnostic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At recruitment
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).
Measured: At recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start12 Jul 2022
- Primary completion30 Apr 2023
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine Disruptor ChemicalsStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe 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
- Cross-sectional
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747365
- Sponsor's protocol ID
- 05C214
- Acronym
- THY-ED
- Status last verified
- Apr 2024
- First submitted
- 17 Feb 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Case-control Study on the Role of Endocrine Disruptors in Thyroid Cancer
- ClinicalTrials.gov ID
- NCT05747365
- Acronym / sponsor ID
- THY-ED / 05C214
- Conditions
- Endocrine Disruptor Chemicals, Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Diagnostic Test: Blood and urine diagnostic evaluationPatients with thyroid cancer diagnosis within 5 years before study enrollment |
| Control group | – | Diagnostic Test: Blood and urine diagnostic evaluationPatients without clinical diagnosis of thyroid disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients referred to our tertiary clinical center for thyroid cancer diagnosed in the last 5 years will be consecutively enrolled (case population). Patients without a diagnosis of thyroid cancer will match patients included in the case population, according to age and sex.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- subjects under 18 years old
- patients unable to sign the informed consent or questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and urine diagnostic evaluationBlood and urine samples will be obtained from both case and control groups in order to evaluate EDCs concentrations | Diagnostic test | Case group, Control group |
Primary outcome
Difference in the average levels of the main endocrine disruptors
Time frame: 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
Relationship between the concentrations of endocrine disruptors and anamnestic variables
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
Related trials for Endocrine Disruptor Chemicals
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
Active, not recruiting
Weight Loss and Endocrine Disrupting Chemicals (EDCs): Lifestyle Interventions to Lose Weight and Reduce EDC Exposure in Individuals With Overweight/Obesity
Obesity &Amp;Amp;Amp; Overweight, Environmental Exposure
Active, not recruitingObservational study
Everyday Exposures: How Chemicals and Weight Impact Breast Cancer Risk
Breast Cancer
Not yet recruiting
Plastic Detox During IVF Treatment
Infertility (IVF Patients)
Not yet recruiting
Reducing Endocrine-Disrupting Chemical Exposure in Reproductive-Age Women: A Pender Model-Based RCT
Women Who Are Aged 18-49 Years, Able to Read, Write
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocrine Disruptor Chemicals and Thyroid Cancer, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Fugazzola, MD (+390261911 ext. 2727, l.fugazzola@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the average levels of the main endocrine disruptors (time frame: At recruitment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.