Advice Protocol to Reduce the Level of Exposure to Metallic Trace Elements (ETM) (ETM)

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.

Study Overview

• Status: Completed
• Conditions: Metallic Trace Elements; Metal-type Environmental Pollutants
• Intervention / Treatment: Diagnostic test: Toxseek test

• Study Type: Observational
• Enrollment (Actual): 185

Contacts and Locations

Study Locations

• France
  • Saint-Rémy-de-Provence, France, 13210
    • Pôle médical Saint Bernard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women, over 18 years old, pregnant (first trimester) or desires conception

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant women or woman in desire for conception; Towseek test : hair taking different questionnaires : environmental questionnaire, compliance questionnaire	Diagnostic test: Toxseek test; Hair taking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months

Collaborators and Investigators

• Sponsor: Elsan
• Collaborators: European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2021
• Primary Completion (Actual): September 3, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2020-A01954-35

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No