HealthyTEXTONCT02210299
TEXTO : Total EXposure To Organic Pollutants
A study testing Exposure study in people with Healthy, run by Rennes University Hospital at 1 site in France.
Trial summary
People are, especially in industrialized countries, exposed to a growing number of ubiquitous chemical substances. It thus increases human exposure pathways: diet, inhalation, soil and dust dermal contact…), notably for semi-volatile organic compounds. Read more about this study
- Who is it for?
- Ages 6 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exposure study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to May 2015
- Phase
- Interventional
- 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 6 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Young children (2-6 months ; 12-18 months)
- In outpatient pediatric or pediatric surgery ;
- From their homes ;
- With home located less than 30km from Rennes ;
- Living at their home (not at childcare facility or child-minder);
- With a scheduled blood sampling apart from this study ;
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- For child 2 - 6 months :
- With diet exclusively based on milk (maternal exclusively or commercial exclusively)
- In case of breastfeeding, with mother accepting milk sampling ;
- With a free, enlightened and signed written consent from the parents.
- Breastfeeding mother :
- > 18 years ;
- Exclusive breastfeeding ;
- With a free, enlightened and signed written consent.
Who cannot join
- Children :
- Metabolic illness ;
- Renal or hepatic insufficiency ;
- Malabsorption
- With known HIV+, HBV+, HCV+, CMV+ serology
- Simultaneously participating to other biomedical survey
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- For breastfeeding mother :
- Under legal protection (judicial protection, guardianship) ;
- mixed breastfeeding ;
- with Known HIV+, HBV+, HCV+, CMV+ serology
Trial locations and contacts
1 site in 1 country.
About this study
People are, especially in industrialized countries, exposed to a growing number of ubiquitous chemical substances. It thus increases human exposure pathways: diet, inhalation, soil and dust dermal contact…), notably for semi-volatile organic compounds. Diet is generally sought to contribute the most to total exposure for many chemicals, the relative contribution of each pathway is nevertheless poorly described, and can be different among populations. This is in particularly the case For young children, who can be more exposed via the environment, because of frequent contact with object and dust and hand to mouth behaviors. Children are in addition considered more sensitive to chemical risk due to their maturating systems.
In this context, the objective of this project is to characterize the young children's exposure to a particular class of semi volatile organic compounds. It will encompass the relative contribution of different pathways to the external dose, and to try to match the internal and external doses with a physiologically based pharmacokinetic (PBPK) model for molecules for which it is possible.
The present demand concerns a feasibility study on 2 children, for Perfluorinated Alkylated Substances (PFAS), used in numerous consumer products.
Read the detailed description
Pilot study for testing feasibility of cross sectional integrative exposure study.
Strategy : Exposure assessment of young children to PFAS with simultaneous measurement of internal (serum) and external doses (diet, indoor environment: contamination data and human exposure factors; quantity ingested and breathed).
Expected outcomes :
Assessment of feasibility to obtain:
- original data on children's body burden
- original contamination data for food, water, air and dust ;
- Matching of these data to identify main sources and pathways of exposure.
- Conditions
- Healthy
- Being tested
- Exposure study
- Keywords
- Healthy young children (2-6 months ; 12-18 months)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure studyOther
Sampling of blood, food, water, air and dust and delivery of dietary questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Exposure study | Other | 2-6 months-old children and 12-18 months-old children Receives: Other: Exposure study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility recruitment
Main objective of this feasibility study is to set the scientific consortium to recruit and study 2 young children's exposures.
Main judgement criteria : Effective enrolment of 2 young children during their consultation to Rennes hospital, from those having a blood sampling for medical purposes, and house survey.
Measured: 3 months
Secondary outcomes (1)
Protocol validation
Second objective is to validate protocols, procedures and methods to study exposure to PFAS.
Secondary judgment criteria :
- Possibility to sample an extra volume of blood, to prepare it and transport it at -18°C to Laberca lab, Nantes;
- Possibility to organize a home visit with sampling of diet, water, air, dust and delivery of dietary questionnaire;
- Possibility to quantify PFAS in dietary and environmental samples;
- Possibility to model the internal dose for some compounds from kinetics data, and to compare doses estimated from blood measurements to those from environmental and diet measurements
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche en Santé, Environnement et le Travail, France, Laboratoire d'Etude des Résidus et Contaminants dans les Aliments, Institut national de l'environnement industriel et des risques, National Agency for Sanitary Safety of the Food of the Environment and Labor
- Responsible party
- Sponsor
- Investigators
- Philippe Glorennec, PhD, Study chair, Inserm UMR 1085 - Institut de Recherche sur la Santé, l'Environnement et le TravailFlorence Rouget, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210299
- Sponsor's protocol ID
- 35RC13_8917_TEXTO
- Other IDs
- 2014-A00782-45, 14/25-941, 140682B-82
- Acronym
- TEXTO
- Status last verified
- Jun 2015
- First submitted
- 5 Aug 2014
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEXTO : Total EXposure To Organic Pollutants
- ClinicalTrials.gov ID
- NCT02210299
- Acronym / sponsor ID
- TEXTO / 35RC13_8917_TEXTO
- Conditions
- Healthy
- Keywords
- Healthy young children (2-6 months ; 12-18 months)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Institut de Recherche en Santé, Environnement et le Travail, France, Laboratoire d'Etude des Résidus et Contaminants dans les Aliments, Institut national de l'environnement industriel et des risques, National Agency for Sanitary Safety of the Food of the Environment and Labor
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Aug 2014 (estimated)
- 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.
People are, especially in industrialized countries, exposed to a growing number of ubiquitous chemical substances. It thus increases human exposure pathways: diet, inhalation, soil and dust dermal contact…), notably for semi-volatile organic compounds. Diet is generally sought to contribute the most to total exposure for many chemicals, the relative contribution of each pathway is nevertheless poorly described, and can be different among populations. This is in particularly the case For young children, who can be more exposed via the environment, because of frequent contact with object and dust and hand to mouth behaviors. Children are in addition considered more sensitive to chemical risk due to their maturating systems.
In this context, the objective of this project is to characterize the young children's exposure to a particular class of semi volatile organic compounds. It will encompass the relative contribution of different pathways to the external dose, and to try to match the internal and external doses with a physiologically based pharmacokinetic (PBPK) model for molecules for which it is possible.
The present demand concerns a feasibility study on 2 children, for Perfluorinated Alkylated Substances (PFAS), used in numerous consumer products.
Detailed description
Pilot study for testing feasibility of cross sectional integrative exposure study.
Strategy : Exposure assessment of young children to PFAS with simultaneous measurement of internal (serum) and external doses (diet, indoor environment: contamination data and human exposure factors; quantity ingested and breathed).
Expected outcomes :
Assessment of feasibility to obtain:
- original data on children's body burden
- original contamination data for food, water, air and dust ;
- Matching of these data to identify main sources and pathways of exposure.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposure study | Other | Other: Exposure study2-6 months-old children and 12-18 months-old children |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Young children (2-6 months ; 12-18 months)
- In outpatient pediatric or pediatric surgery ;
- From their homes ;
- With home located less than 30km from Rennes ;
- Living at their home (not at childcare facility or child-minder);
Key exclusion criteria (10 listed)
- Metabolic illness ;
- Renal or hepatic insufficiency ;
- Malabsorption
- With known HIV+, HBV+, HCV+, CMV+ serology
- Simultaneously participating to other biomedical survey
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 |
|---|---|---|
| Exposure studySampling of blood, food, water, air and dust and delivery of dietary questionnaire | Other | Exposure study |
Primary outcome
Feasibility recruitment
Time frame: 3 months
Main objective of this feasibility study is to set the scientific consortium to recruit and study 2 young children's exposures. Main judgement criteria : Effective enrolment of 2 young children during their consultation to Rennes hospital, from those having a blood sampling for medical purposes, and house survey.
1 secondary outcome
Protocol validation
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
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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.
Philippe Glorennec, PhD study chair
Inserm UMR 1085 - Institut de Recherche sur la Santé, l'Environnement et le Travail
Florence Rouget, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure study in people with Healthy, run by Rennes University Hospital at 1 site in France.
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 14 inclusion and 10 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: withdrawn, as of the sponsor's last update on 10 Jun 2015. 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 France. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility recruitment (time frame: 3 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 10 Jun 2015.