Metallic Trace ElementsETMNCT05144438
Advice Protocol to Reduce the Level of Exposure to Metallic Trace Elements (ETM)
An observational study of Metallic Trace Elements and Metal-type Environmental Pollutants, run by Elsan at 1 site in France.
Trial summary
A French company (Toxseek, France, has developed a scientifically validated screening test based on a capillary determination of pollutants on a 3 cm lock of hair. The results of this screening allow physicians to discuss with their patients the question of environmental health and provide them with personalized… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metallic Trace Elements, Metal-type Environmental Pollutants
- What is being tested?
- Toxseek test
- How many people
- 185 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2021to 30 Sep 2022
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women, over 18 years old, pregnant (first trimester) or desires conception
Who may be able to join
- Women over 18 years old
- Patient with desire to conceive
- 1st trimester of pregnancy
- Patient having been informed of the study and not opposing the use of the data collected
- Affiliate or beneficiary of a social security scheme
Who cannot join
- Women under 18 years old
- 2nd and 3rd trimester of pregnancy
- Patient objecting to the use of the data collected
- Protected patient: adult under tutorship, curatorship or other protection legal, deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of the Effectiveness of a Counseling Protocol to Reduce the Level of Exposure to Metallic Trace Elements (ETM)
A French company (Toxseek, France, has developed a scientifically validated screening test based on a capillary determination of pollutants on a 3 cm lock of hair. The results of this screening allow physicians to discuss with their patients the question of environmental health and provide them with personalized behavioral advice in an attempt to eliminate the source of the pollutants identified.The main objective of the study is to assess the effectiveness of behavioral counseling on reducing the level of exposure to metal-type environmental pollutants (MTE) in pregnant women or women planning to have children.
- Being tested
- Toxseek test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toxseek testDiagnostic test
Hair taking
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women or woman in desire for conception | Towseek test : hair taking different questionnaires : environmental questionnaire, compliance questionnaire Receives: Diagnostic Test: Toxseek test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who reduced their level of exposure within 4 months of metal avoidance advice.
The patient will be considered "successful" for the reduction of the exposure level, if all the metals with a "risky" exposure level during the 1st screening have gone to an exposure level "to be monitored" or "acceptable" during the 2nd screening.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start3 Jan 2021
- Primary completion3 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metallic Trace ElementsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144438
- Sponsor's protocol ID
- 2020-A01954-35
- Acronym
- ETM
- Status last verified
- Oct 2022
- First submitted
- 23 Nov 2021
- Last updated
- 19 Oct 2022
- 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 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Effectiveness of a Counseling Protocol to Reduce the Level of Exposure to Metallic Trace Elements (ETM)
- ClinicalTrials.gov ID
- NCT05144438
- Acronym / sponsor ID
- ETM / 2020-A01954-35
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 3 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 3 Dec 2021 (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.
A French company (Toxseek, France, has developed a scientifically validated screening test based on a capillary determination of pollutants on a 3 cm lock of hair. The results of this screening allow physicians to discuss with their patients the question of environmental health and provide them with personalized behavioral advice in an attempt to eliminate the source of the pollutants identified.The main objective of the study is to assess the effectiveness of behavioral counseling on reducing the level of exposure to metal-type environmental pollutants (MTE) in pregnant women or women planning to have children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women or woman in desire for conception | – | Diagnostic Test: Toxseek testTowseek test : hair taking different questionnaires : environmental questionnaire, compliance questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women, over 18 years old, pregnant (first trimester) or desires conception
Key inclusion criteria (5 listed)
- Women over 18 years old
- Patient with desire to conceive
- 1st trimester of pregnancy
- Patient having been informed of the study and not opposing the use of the data collected
- Affiliate or beneficiary of a social security scheme
Key exclusion criteria (4 listed)
- Women under 18 years old
- 2nd and 3rd trimester of pregnancy
- Patient objecting to the use of the data collected
- Protected patient: adult under tutorship, curatorship or other protection legal, deprived of liberty by judicial or administrative decision
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 |
|---|---|---|
| Toxseek testHair taking | Diagnostic test | Pregnant women or woman in desire for conception |
Primary outcome
Proportion of patients who reduced their level of exposure within 4 months of metal avoidance advice.
Time frame: 4 months
The patient will be considered "successful" for the reduction of the exposure level, if all the metals with a "risky" exposure level during the 1st screening have gone to an exposure level "to be monitored" or "acceptable" during the 2nd screening.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metallic Trace Elements and Metal-type Environmental Pollutants, run by Elsan 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 19 Oct 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients who reduced their level of exposure within 4 months of metal avoidance advice. (time frame: 4 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 19 Oct 2022.