EndometriosisFTALATENDONCT05551494
Urinary Concentration of Phthalate Metabolites in Women With and Without Endometriosis
An observational study of Endometriosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Exposure to endocrine-disrupting chemicals can considerably affect female reproductive system. Exposure can occur in living environments and in specific workplaces in which these substances are produced or used. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Urinary sample
- How many people
- 440 participants
- Where
- 1 siteItaly
- Study dates
- 22 Mar 2022to 30 Mar 2024
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: In this study will be recruited women with or without endometriosis, aged 18-45 years who have lived in the last 10 years in the Lombardy area. Will be excluded women with uterine fibroids, gynecological cancers or renal, hepatic, cardiovascular disease, diabetes or high blood pressure
Who may be able to join
- Endometriosis group are women aged 18-45 with a diagnosis of endometriosis who report having lived in the past ten years in the Lombardy area.
- Control group are women aged 18-45 who do not have endometriosis who report having lived in the past ten years in the Lombardy area.
Who cannot join
- Pregnancy
- Uterine fibroids, gynecological cancers
- Renal, hepatic, cardiovascolar disease, diabetes or high blood pressure
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, 20122
Laura buggio, MD, +393388720855, laura.buggio@policlinico.mi.it
Dhouha Dridi, MD, +393429370961, dhouha.dridi@policlinico.mi.it
About this study
Official title: Urinary Concentration of Phthalate Metabolites in Women With and Without Endometriosis: a Case-control Study
Exposure to endocrine-disrupting chemicals can considerably affect female reproductive system. Exposure can occur in living environments and in specific workplaces in which these substances are produced or used. Among endocrinedisrupting chemicals, phthalates, dialkyl esters or alkyl aryl esters of orthophthalic acid (1,2-dicarboxylic acid) represent a group of structurally similar molecules, widely used in industry since 1930 in numerous manufacture processes, mainly as a plasticizer.
These substances present dangerous characteristics, particularly associated with reproductive toxicity, and their xenoestrogenicity led some authors to evaluate a possible involvement in the aetiology of endometriosis.
Read more
In this proposed study the investigators aim to clarify a potential association between endometriosis and phthalates exposure.
Women with a diagnosis of endometriosis will be recruited as "cases" while women without endometriosis as "controls". An "ad hoc" questionnaire will be administered to the patient to collect the necessary information on the characteristics of endometriosis as well as their lifestyle and work habits.
The biological monitoring will be carried out measuring the urinary levels of phthalate metabolites. In order to produce reliable data and to reduce the possible contamination caused by the contact with plastic materials, samples will be analyzed by High Performance Liquid Chromatography/Tandem Mass Spectrometry (HPLC-MS/MS).
A statistical elaboration of the data will clarify possible identifiable risk factors and associations with specific clinical situations.
The investigators expect that women with endometriosis may present higher levels of phthalates compared with women without the disease. In particular, the investigators hypothesize that women with the most severe form of the disease [i.e. deep infiltrating endometriosis (DIE)] may present the highest levels. These study findings will provide valuable suggestions for developing effective strategies to prevent endometriosis.
Read the detailed description
Exposure to phthalates can considerably affect female reproductive system. Recent evidence suggests that one of the diseases related to the high concentration of phthalate metabolites in biological fluids might be endometriosis.
This case-control study aims to evaluate the relationship between endometriosis and phthalates exposure through biomarkers analysis in urine. The investigators hypothesize that women with endometriosis, particularly those with deep infiltrating forms (i.e. the most severe form of the disease), will show higher urinary phthalate metabolites compared to women with ovarian/peritoneal forms and those without endometriosis. When deep lesions and ovarian lesions co-existed, the woman will be included in the deep infiltrating subgroup, as the former lesions are considered more severe than the latter ones.
The identification of a possible environmental risk, such as the exposure to phthalates, could allow the implementation of preventive measures aimed at reducing the exposure to such contaminants. Moreover, clinical data obtained may contribute to a better understanding of the etiology and the pathophysiology of endometriosis.
The main objective of the present study is to evaluate the levels of exposure to phthalates of a female population with endometriosis and to understand if it differs significantly from a population of women without the disease.
Identifying a possible relationship between urinary phthalates metabolite concentrations and the risk of endometriosis could represent a valuable tool for implementing specific preventive measures, especially in the workplace.
The results of our case-control study aim to shed more light on the potential association between endometriosis and phthalate exposure, specifically in the Italian context.
Secondary objectives include:
- to evaluate potential variations in urinary phthalate metabolite levels in women with different phenotypes of the disease: peritoneal endometriosis, ovarian endometriosis, deep infiltrating endometriosis.
- to evaluate potential variations in the levels of urinary phthalate metabolite in endometriosis patients in relation to the presence and levels of pain symptoms (dysmenorrhea, chronic pelvic pain, deep dyspareunia) and/or infertility.
The causality study will try to identify possible routes of exposure in everyday life and/or working environments, which could represent a possible source of risk. The results could identify work context in which health risks for women could be highly diversified from those for men. This identification could support the competent doctors in defining health surveillance protocols for specific sectors.
- Conditions
- Endometriosis
- Being tested
- Urinary sample
- Keywords
- phthalates, urinary biomarkers, endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary sampleDiagnostic test
At study entry, we will collect urinary samples from women. Participants will be asked with an interview on demographic and lifestyle characteristics, health-related behaviours, the existence and duration of infertility, medical history, and history of hormonal or surgical treatments for endometriosis. Pain symptoms will be evaluated through a 10 cm long one-dimensional visual-analogue scale (VAS).
In addition, women will be asked to report about their habits about consumption of plastic
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis group | Cases will include women aged 18-45 with a surgical diagnosis of endometriosis in the previous 24 months or with a current nonsurgical diagnosis of endometriosis who report having lived in the past ten years in the Lombardy area. At study entry, we will collect urinary sample. Receives: Diagnostic Test: Urinary sample | |
| Control group | Control group are women aged 18-45 attending our outpatient clinic for periodical gynaecological care, contraception, or cervical cancer screening programme, and without a previous clinical or surgical diagnosis of endometriosis who report having lived in the past ten years in the Lombardy area. At study entry, we will collect urinary sample. Receives: Diagnostic Test: Urinary sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate urinary concentration of phthalates
The main objective of the present study is to evaluate the levels of exposure to phthalates of a female population with endometriosis and to understand if it differs significantly from a population of women without the disease. Identifying a possible relationship between urinary phthalates metabolite concentrations and the risk of endometriosis could represent a valuable tool for implementing specific preventive measures, especially in the workplace
Measured: 24 months
Secondary outcomes (4)
Variations in urinary concentration phthalate metabolite levels in women with different phenotypes of the disease
To evaluate potential variations in urinary phthalate metabolite levels in women with different phenotypes of the disease: peritoneal endometriosis, ovarian endometriosis, deep infiltrating endometriosis.
Measured: 24 months
Variations in urinary concentration phthalate metabolite levels in women with different symptoms of the disease
to evaluate potential variations in the levels of urinary phthalate metabolite in endometriosis patients in relation to the presence and levels of pain symptoms (dysmenorrhea, chronic pelvic pain, deep dyspareunia) and/or infertility.
Measured: 24 months
Identify possible routes of exposure in everyday life and/or working environments
to evaluate potential confounders
Measured: 24 months
Identify work context in which health risks for women could be highly than for men
to evaluate potential factors related to work context
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start22 Mar 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- 440 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Direzione Ginecologia, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Laura Buggio, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551494
- Sponsor's protocol ID
- 2706
- Acronym
- FTALATENDO
- Status last verified
- Sep 2022
- First submitted
- 23 Aug 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Concentration of Phthalate Metabolites in Women With and Without Endometriosis: a Case-control Study
- ClinicalTrials.gov ID
- NCT05551494
- Acronym / sponsor ID
- FTALATENDO / 2706
- Conditions
- Endometriosis
- Keywords
- phthalates, urinary biomarkers, endometriosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 22 Sep 2022 (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.
Exposure to endocrine-disrupting chemicals can considerably affect female reproductive system. Exposure can occur in living environments and in specific workplaces in which these substances are produced or used. Among endocrinedisrupting chemicals, phthalates, dialkyl esters or alkyl aryl esters of orthophthalic acid (1,2-dicarboxylic acid) represent a group of structurally similar molecules, widely used in industry since 1930 in numerous manufacture processes, mainly as a plasticizer.
These substances present dangerous characteristics, particularly associated with reproductive toxicity, and their xenoestrogenicity led some authors to evaluate a possible involvement in the aetiology of endometriosis.
In this proposed study the investigators aim to clarify a potential association between endometriosis and phthalates exposure.
Women with a diagnosis of endometriosis will be recruited as "cases" while women without endometriosis as "controls". An "ad hoc" questionnaire will be administered to the patient to collect the necessary information on the characteristics of endometriosis as well as their lifestyle and work habits.
The biological monitoring will be carried out measuring the urinary levels of phthalate metabolites. In order to produce reliable data and to reduce the possible contamination caused by the contact with plastic materials, samples will be analyzed by High Performance Liquid Chromatography/Tandem Mass Spectrometry (HPLC-MS/MS).
A statistical elaboration of the data will clarify possible identifiable risk factors and associations with specific clinical situations.
The investigators expect that women with endometriosis may present higher levels of phthalates compared with women without the disease. In particular, the investigators hypothesize that women with the most severe form of the disease [i.e. deep infiltrating endometriosis (DIE)] may present the highest levels. These study findings will provide valuable suggestions for developing effective strategies to prevent endometriosis.
Detailed description
Exposure to phthalates can considerably affect female reproductive system. Recent evidence suggests that one of the diseases related to the high concentration of phthalate metabolites in biological fluids might be endometriosis.
This case-control study aims to evaluate the relationship between endometriosis and phthalates exposure through biomarkers analysis in urine. The investigators hypothesize that women with endometriosis, particularly those with deep infiltrating forms (i.e. the most severe form of the disease), will show higher urinary phthalate metabolites compared to women with ovarian/peritoneal forms and those without endometriosis. When deep lesions and ovarian lesions co-existed, the woman will be included in the deep infiltrating subgroup, as the former lesions are considered more severe than the latter ones.
The identification of a possible environmental risk, such as the exposure to phthalates, could allow the implementation of preventive measures aimed at reducing the exposure to such contaminants. Moreover, clinical data obtained may contribute to a better understanding of the etiology and the pathophysiology of endometriosis.
The main objective of the present study is to evaluate the levels of exposure to phthalates of a female population with endometriosis and to understand if it differs significantly from a population of women without the disease.
Identifying a possible relationship between urinary phthalates metabolite concentrations and the risk of endometriosis could represent a valuable tool for implementing specific preventive measures, especially in the workplace.
The results of our case-control study aim to shed more light on the potential association between endometriosis and phthalate exposure, specifically in the Italian context.
Secondary objectives include:
- to evaluate potential variations in urinary phthalate metabolite levels in women with different phenotypes of the disease: peritoneal endometriosis, ovarian endometriosis, deep infiltrating endometriosis.
- to evaluate potential variations in the levels of urinary phthalate metabolite in endometriosis patients in relation to the presence and levels of pain symptoms (dysmenorrhea, chronic pelvic pain, deep dyspareunia) and/or infertility.
The causality study will try to identify possible routes of exposure in everyday life and/or working environments, which could represent a possible source of risk. The results could identify work context in which health risks for women could be highly diversified from those for men. This identification could support the competent doctors in defining health surveillance protocols for specific sectors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis group | – | Diagnostic Test: Urinary sampleCases will include women aged 18-45 with a surgical diagnosis of endometriosis in the previous 24 months or with a current nonsurgical diagnosis of endometriosis who report having lived in the past ten years in the Lombardy area. At study entry, we will collect urinary sample. |
| Control group | – | Diagnostic Test: Urinary sampleControl group are women aged 18-45 attending our outpatient clinic for periodical gynaecological care, contraception, or cervical cancer screening programme, and without a previous clinical or surgical diagnosis of endometriosis who report having lived in the past ten years in the Lombardy area. At study entry, we will collect urinary sample. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In this study will be recruited women with or without endometriosis, aged 18-45 years who have lived in the last 10 years in the Lombardy area. Will be excluded women with uterine fibroids, gynecological cancers or renal, hepatic, cardiovascular disease, diabetes or high blood pressure
Key inclusion criteria (2 listed)
- Endometriosis group are women aged 18-45 with a diagnosis of endometriosis who report having lived in the past ten years in the Lombardy area.
- Control group are women aged 18-45 who do not have endometriosis who report having lived in the past ten years in the Lombardy area.
Key exclusion criteria (3 listed)
- Pregnancy
- Uterine fibroids, gynecological cancers
- Renal, hepatic, cardiovascolar disease, diabetes or high blood pressure
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 |
|---|---|---|
| Urinary sampleAt study entry, we will collect urinary samples from women. Participants will be asked with an interview on demographic and lifestyle characteristics, health-related behaviours, the existence and duration of infertility, medical history, and history of hormonal or surgical treatments for endometriosis. Pain symptoms will be evaluated through a 10 cm long one-dimensional visual-analogue scale (VAS). In addition, women will be asked to report about their habits about consumption of plastic | Diagnostic test | Control group, Endometriosis group |
Primary outcome
Evaluate urinary concentration of phthalates
Time frame: 24 months
The main objective of the present study is to evaluate the levels of exposure to phthalates of a female population with endometriosis and to understand if it differs significantly from a population of women without the disease. Identifying a possible relationship between urinary phthalates metabolite concentrations and the risk of endometriosis could represent a valuable tool for implementing specific preventive measures, especially in the workplace
4 secondary outcomes
Variations in urinary concentration phthalate metabolite levels in women with different phenotypes of the disease
Time frame: 24 months
Variations in urinary concentration phthalate metabolite levels in women with different symptoms of the disease
Time frame: 24 months
Identify possible routes of exposure in everyday life and/or working environments
Time frame: 24 months
Identify work context in which health risks for women could be highly than for men
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Laura Buggio, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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 Endometriosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico 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 3 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 22 Sep 2022. 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 Paolo Vercellini, Professor (0255032218, paolo.vercellini@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate urinary concentration of phthalates (time frame: 24 months). 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 22 Sep 2022.