Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628375
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
A Multimodal Study of the Relationship Between Exposure to Endocrine Disruptors and Occurrence of Hypospadias - HYPOLLUT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exposure to Endocrine Disruptors and Occurrence of Hypospadias Toxicological Environmental and Hormonal Imbalance Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYPOLLUT
Brief Summary:
This study aims to demonstrate the impact of Endocrine-Disrupting Chemicals EDCs on the risk of hypospadias incidence It is a multicenter comparative case-control study involving two groups The first group consists of biological mothers who have given birth to children with hypospadias Case Group while the second group consists of biological mothers who have given birth to children without any malformations Control Group Through an integrative approach that combines a direct toxicological study of numerous pollutants present during pregnancy and a comprehensive exposome assessment using validated tools this study can significantly enhance our understanding and prevention of this malformation
Detailed Description:
Background Hypospadias is a birth defect of the external genital organs in boys and it ranks the second most common genital malformation in male newborns following cryptorchidism Its prevalence is increasing in certain global regions with an estimated rate of 38 cases per 1000 male births To date the exact cause of hypospadias remains unknown however genetic hormonal and environmental factors are likely involved Medical and surgical treatment may be necessary Furthermore hypospadias is correlated with fertility issues and is also linked to testicular cancer
Aim After ruling out hypospadias with a genetic cause the aim of this study is to evaluate any significant differences to environmental endocrine disrupting-chemicals EDCs exposure between biological mothers of children with hypospadias and those with children without malformation It aims to demonstrate that this exposure professional occupational environmental leads to hormonal changes during the neonatal mini-puberty period
Methods This research will be conducted as a multicenter case-control study mother and son with isolated anterior or middle hypospadias Case Group and mother and son without hypospadias Control Group The clinical investigator plans to enroll 200 patients
A single visit will be performed This consultation is part of the usual follow-up for children in the Case Group while it is specific to the project for children in the Control Group
During this visit the investigator
will establish the diagnosis of hypospadias for cases or absence of genital anomaly for controls
will lead an interview using a questionnaire and a job-exposure matrix to assess EDCs during pregnancy
will take a hair sample from the mother to measure the substances accumulated during pregnancy
and finally will take a blood sample from the child for hormonal evaluation of mini-puberty and another blood sample from child in the Case Group for analysis and the participation in a DNA collection
Aim After ruling out hypospadias with a genetic cause the aim of this study is to evaluate any significant differences to environmental endocrine disrupting-chemicals EDCs exposure between biological mothers of children with hypospadias and those with children without malformation It aims to demonstrate that this exposure professional occupational environmental leads to hormonal changes during the neonatal mini-puberty period
Methods This research will be conducted as a multicenter case-control study mother and son with isolated anterior or middle hypospadias Case Group and mother and son without hypospadias Control Group The clinical investigator plans to enroll 200 patients
A single visit will be performed This consultation is part of the usual follow-up for children in the Case Group while it is specific to the project for children in the Control Group
During this visit the investigator
will establish the diagnosis of hypospadias for cases or absence of genital anomaly for controls
will lead an interview using a questionnaire and a job-exposure matrix to assess EDCs during pregnancy
will take a hair sample from the mother to measure the substances accumulated during pregnancy
and finally will take a blood sample from the child for hormonal evaluation of mini-puberty and another blood sample from child in the Case Group for analysis and the participation in a DNA collection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None