HypospadiasHYPOLLUTNCT06628375
A Multimodal Study of the Relationship Between Exposure to Endocrine Disruptors and Occurrence of Hypospadias - HYPOLLUT
An observational study of Hypospadias, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month and olderHealthy volunteers can take part
- Conditions the study is for
- Hypospadias
- What is being tested?
- Consultation visit (Visit 1)
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2024to 3 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 month and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Case Group: Biological mother and child with hypospadias Control group: Biological mother and child without hypospadias
Who may be able to join
None listed.
Who cannot join
- Child with another congenital anomaly or malformative syndrome
- Child with an endocrine pathology
- Biological mother or child under legal protection, guardianship, or curatorship
- Biological mother or child in the exclusion period of a previous study
- Biological mother or child included in another clinical study involving a drug
- Specific Exclusion Criteria for Case Group:
- Biological mother/child pairs if a genetic variant explaining hypospadias is found during genetic analysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CRMR DEVGEN CHU Lapeyronnie
Montpellier, Hérault, 34090
About this study
Official title: Exposure to Endocrine Disruptors and Occurrence of Hypospadias: Toxicological, Environmental and Hormonal Imbalance Study
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.
Read the 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 3.8 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
- Conditions
- Hypospadias
- Being tested
- Consultation visit (Visit 1)
- Keywords
- Endocrine-disrupting chemicals, Birth defect, Environment, Hormones minipuberty, Exposome, Toxicology hair
- Medical subject headings
- Hypospadias, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consultation visit (Visit 1)Other
During visit 1, a pediatric urologist or pediatric endocrinologist will perform a clinical examination to confirm the diagnosis of hypospadias, as a part of routine care. The clinical study investigator will ask to fill out a validated European questionnaire for the exposome and use an occupation/exposure matrix to identify specific atmospheric exposure.
A hair sample from the biological mother will be taken for toxicological evaluation of substances accumulated during pregnancy.
From the child, a blood sample will be taken for hormonal evaluation of minipuberty and then, another sample in a 5 ml EDTA tube will be taken for DNA collection.
Consultation visit (Visit 1)Other
During visit 1, a pediatric urologist or pediatric endocrinologist will perform a clinical examination to confirm the absence of hypospadias. The clinical study investigator will ask to fill out a validated European questionnaire for the exposome and use an occupation/exposure matrix to identify specific atmospheric exposure.
A hair sample from the biological mother will be taken for toxicological evaluation of substances accumulated during pregnancy.
From the child, a blood sample will be taken for hormonal evaluation of minipuberty.
| Study group | Role | What they receive |
|---|---|---|
| Case Group | Biological mother and son with hypospadias Receives: Other: Consultation visit (Visit 1) | |
| Control Group | Biological mother and son without hypospadias Receives: Other: Consultation visit (Visit 1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of toxic exposure via hair sample analysis
An assessment of toxic substance concentrations in maternal hair will evaluate exposure to a wide range of pollutants. The collected hair samples will provide data representing the period from three months before conception to the date of study enrollment.
The study will analyze 150 chemical substances and measure their concentrations to assess mothers' exposure to these pollutants during pregnancy.
Measured: Day 1 (Visit 1)
Secondary outcomes (4)
Exposome through validated European questionnaires (QLK4-1999-01422)
Evaluation of parents' environmental exposure (exposome) will be conducted using a simplified version of a validated European questionnaire. This approach aims to elucidate potential differences in exposure between case and control groups.
Measured: Day 1 (Visit 1)
Exposome professionnel
Assessment by the job-exposure matrix EDC (Environment disrupting chemicals)
Measured: Day 1 (Visit 1)
Pollutant dispersion model
Examination of atmospheric pollutant concentration measurements and their potential impact on maternal exposure during gestation. This study conducts a comparative analysis between two groups: mothers of affected children (case group) and mothers of unaffected children (control group).
Measured: Day 1 (Visit 1)
Hormonal analysis by immunoassay principle
Measurement of plasma hormone levels of mini-puberty to investigate a correlation between toxicological dosage and endocrine disruption. FSH, LH, AMH and free Testosterone will be measured by Electrochemiluminescence and Inhibin B by ELISA assay. This assessment of a mini-puberty alteration will be carried out by comparing age-based norms and the values of the control group
Measured: Day 1 (Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start3 Oct 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion3 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas KALFA, Prof, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628375
- Sponsor's protocol ID
- RECHMPL22_0559
- Acronym
- HYPOLLUT
- Status last verified
- Nov 2025
- First submitted
- 25 Sep 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ea V, Bergougnoux A, Philibert P, Servant-Fauconnet N, Faure A, Breaud J, Gaspari L, Sultan C, Paris F, Kalfa N. How Far Should We Explore Hypospadias? Next-generation Sequencing Applied to a Large Cohort of Hypospadiac Patients. Eur Urol. 2021 Apr;79(4):507-515. doi: 10.1016/j.eururo.2020.12.036. Epub 2021 Jan 16.
PubMed 33468338Skakkebaek NE, Rajpert-De Meyts E, Main KM. Testicular dysgenesis syndrome: an increasingly common developmental disorder with environmental aspects. Hum Reprod. 2001 May;16(5):972-8. doi: 10.1093/humrep/16.5.972.
PubMed 11331648Skarin Nordenvall A, Chen Q, Norrby C, Lundholm C, Frisen L, Nordenstrom A, Almqvist C, Nordenskjold A. Fertility in adult men born with hypospadias: A nationwide register-based cohort study on birthrates, the use of assisted reproductive technologies and infertility. Andrology. 2020 Mar;8(2):372-380. doi: 10.1111/andr.12723. Epub 2019 Nov 20.
PubMed 31670475Springer A, van den Heijkant M, Baumann S. Worldwide prevalence of hypospadias. J Pediatr Urol. 2016 Jun;12(3):152.e1-7. doi: 10.1016/j.jpurol.2015.12.002. Epub 2015 Dec 31.
PubMed 26810252Schneuer FJ, Milne E, Jamieson SE, Pereira G, Hansen M, Barker A, Holland AJA, Bower C, Nassar N. Association between male genital anomalies and adult male reproductive disorders: a population-based data linkage study spanning more than 40 years. Lancet Child Adolesc Health. 2018 Oct;2(10):736-743. doi: 10.1016/S2352-4642(18)30254-2. Epub 2018 Aug 30.
PubMed 30236382Asklund C, Jensen TK, Main KM, Sobotka T, Skakkebaek NE, Jorgensen N. Semen quality, reproductive hormones and fertility of men operated for hypospadias. Int J Androl. 2010 Feb;33(1):80-7. doi: 10.1111/j.1365-2605.2009.00957.x. Epub 2009 Mar 5.
PubMed 19281491Kumar S, Tomar V, Yadav SS, Priyadarshi S, Vyas N, Agarwal N. Fertility Potential in Adult Hypospadias. J Clin Diagn Res. 2016 Aug;10(8):PC01-5. doi: 10.7860/JCDR/2016/21307.8276. Epub 2016 Aug 1.
PubMed 27656497Serrano T, Chevrier C, Multigner L, Cordier S, Jegou B. International geographic correlation study of the prevalence of disorders of male reproductive health. Hum Reprod. 2013 Jul;28(7):1974-86. doi: 10.1093/humrep/det111. Epub 2013 May 12.
PubMed 23670171Cortes D, Thorup JM, Visfeldt J. Cryptorchidism: aspects of fertility and neoplasms. A study including data of 1,335 consecutive boys who underwent testicular biopsy simultaneously with surgery for cryptorchidism. Horm Res. 2001;55(1):21-7. doi: 10.1159/000049959.
PubMed 11423738Pettersson A, Richiardi L, Nordenskjold A, Kaijser M, Akre O. Age at surgery for undescended testis and risk of testicular cancer. N Engl J Med. 2007 May 3;356(18):1835-41. doi: 10.1056/NEJMoa067588.
PubMed 17476009Xing JS, Bai ZM. Is testicular dysgenesis syndrome a genetic, endocrine, or environmental disease, or an unexplained reproductive disorder? Life Sci. 2018 Feb 1;194:120-129. doi: 10.1016/j.lfs.2017.11.039. Epub 2017 Nov 26.
PubMed 29183799Olesen IA, Sonne SB, Hoei-Hansen CE, Rajpert-De Meyts E, Skakkebaek NE. Environment, testicular dysgenesis and carcinoma in situ testis. Best Pract Res Clin Endocrinol Metab. 2007 Sep;21(3):462-78. doi: 10.1016/j.beem.2007.04.002.
PubMed 17875492Stillman RJ. In utero exposure to diethylstilbestrol: adverse effects on the reproductive tract and reproductive performance and male and female offspring. Am J Obstet Gynecol. 1982 Apr 1;142(7):905-21. doi: 10.1016/s0002-9378(16)32540-6.
PubMed 6121486Lymperi S, Giwercman A. Endocrine disruptors and testicular function. Metabolism. 2018 Sep;86:79-90. doi: 10.1016/j.metabol.2018.03.022. Epub 2018 Mar 29.
PubMed 29605435Kalfa N, Paris F, Soyer-Gobillard MO, Daures JP, Sultan C. Prevalence of hypospadias in grandsons of women exposed to diethylstilbestrol during pregnancy: a multigenerational national cohort study. Fertil Steril. 2011 Jun 30;95(8):2574-7. doi: 10.1016/j.fertnstert.2011.02.047. Epub 2011 Apr 2.
PubMed 21458804
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure to Endocrine Disruptors and Occurrence of Hypospadias: Toxicological, Environmental and Hormonal Imbalance Study
- ClinicalTrials.gov ID
- NCT06628375
- Acronym / sponsor ID
- HYPOLLUT / RECHMPL22_0559
- Conditions
- Hypospadias
- Keywords
- Endocrine-disrupting chemicals, Birth defect, Environment, Hormones minipuberty, Exposome, Toxicology hair
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 3 Oct 2027 (estimated)
- First posted
- 8 Oct 2024 (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.
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 3.8 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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Other: Consultation visit (Visit 1)Biological mother and son with hypospadias |
| Control Group | – | Other: Consultation visit (Visit 1)Biological mother and son without hypospadias |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Case Group: Biological mother and child with hypospadias Control group: Biological mother and child without hypospadias
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Child with another congenital anomaly or malformative syndrome
- Child with an endocrine pathology
- Biological mother or child under legal protection, guardianship, or curatorship
- Biological mother or child in the exclusion period of a previous study
- Biological mother or child included in another clinical study involving a drug
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 |
|---|---|---|
| Consultation visit (Visit 1)During visit 1, a pediatric urologist or pediatric endocrinologist will perform a clinical examination to confirm the diagnosis of hypospadias, as a part of routine care. The clinical study investigator will ask to fill out a validated European questionnaire for the exposome and use an occupation/exposure matrix to identify specific atmospheric exposure. A hair sample from the biological mother will be taken for toxicological evaluation of substances accumulated during pregnancy. From the child, a blood sample will be taken for hormonal evaluation of minipuberty and then, another sample in a 5 ml EDTA tube will be taken for DNA collection. | Other | Case Group |
| Consultation visit (Visit 1)During visit 1, a pediatric urologist or pediatric endocrinologist will perform a clinical examination to confirm the absence of hypospadias. The clinical study investigator will ask to fill out a validated European questionnaire for the exposome and use an occupation/exposure matrix to identify specific atmospheric exposure. A hair sample from the biological mother will be taken for toxicological evaluation of substances accumulated during pregnancy. From the child, a blood sample will be taken for hormonal evaluation of minipuberty. | Other | Control Group |
Primary outcome
Evaluation of toxic exposure via hair sample analysis
Time frame: Day 1 (Visit 1)
An assessment of toxic substance concentrations in maternal hair will evaluate exposure to a wide range of pollutants. The collected hair samples will provide data representing the period from three months before conception to the date of study enrollment. The study will analyze 150 chemical substances and measure their concentrations to assess mothers' exposure to these pollutants during pregnancy.
4 secondary outcomes
Exposome through validated European questionnaires (QLK4-1999-01422)
Time frame: Day 1 (Visit 1)
Exposome professionnel
Time frame: Day 1 (Visit 1)
Pollutant dispersion model
Time frame: Day 1 (Visit 1)
Hormonal analysis by immunoassay principle
Time frame: Day 1 (Visit 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Background: PubMed 33468338Ea V, Bergougnoux A, Philibert P, Servant-Fauconnet N, Faure A, Breaud J, Gaspari L, Sultan C, Paris F, Kalfa N. How Far Should We Explore Hypospadias? Next-generation Sequencing Applied to a Large Cohort of Hypospadiac Patients. Eur Urol. 2021 Apr;79(4):507-515. doi: 10.1016/j.eururo.2020.12.036. Epub 2021 Jan 16.
- Background: PubMed 11331648Skakkebaek NE, Rajpert-De Meyts E, Main KM. Testicular dysgenesis syndrome: an increasingly common developmental disorder with environmental aspects. Hum Reprod. 2001 May;16(5):972-8. doi: 10.1093/humrep/16.5.972.
- Background: PubMed 31670475Skarin Nordenvall A, Chen Q, Norrby C, Lundholm C, Frisen L, Nordenstrom A, Almqvist C, Nordenskjold A. Fertility in adult men born with hypospadias: A nationwide register-based cohort study on birthrates, the use of assisted reproductive technologies and infertility. Andrology. 2020 Mar;8(2):372-380. doi: 10.1111/andr.12723. Epub 2019 Nov 20.
- Background: PubMed 26810252Springer A, van den Heijkant M, Baumann S. Worldwide prevalence of hypospadias. J Pediatr Urol. 2016 Jun;12(3):152.e1-7. doi: 10.1016/j.jpurol.2015.12.002. Epub 2015 Dec 31.
- Background: PubMed 30236382Schneuer FJ, Milne E, Jamieson SE, Pereira G, Hansen M, Barker A, Holland AJA, Bower C, Nassar N. Association between male genital anomalies and adult male reproductive disorders: a population-based data linkage study spanning more than 40 years. Lancet Child Adolesc Health. 2018 Oct;2(10):736-743. doi: 10.1016/S2352-4642(18)30254-2. Epub 2018 Aug 30.
- Background: PubMed 19281491Asklund C, Jensen TK, Main KM, Sobotka T, Skakkebaek NE, Jorgensen N. Semen quality, reproductive hormones and fertility of men operated for hypospadias. Int J Androl. 2010 Feb;33(1):80-7. doi: 10.1111/j.1365-2605.2009.00957.x. Epub 2009 Mar 5.
- Background: PubMed 27656497Kumar S, Tomar V, Yadav SS, Priyadarshi S, Vyas N, Agarwal N. Fertility Potential in Adult Hypospadias. J Clin Diagn Res. 2016 Aug;10(8):PC01-5. doi: 10.7860/JCDR/2016/21307.8276. Epub 2016 Aug 1.
- Background: PubMed 23670171Serrano T, Chevrier C, Multigner L, Cordier S, Jegou B. International geographic correlation study of the prevalence of disorders of male reproductive health. Hum Reprod. 2013 Jul;28(7):1974-86. doi: 10.1093/humrep/det111. Epub 2013 May 12.
- Background: PubMed 11423738Cortes D, Thorup JM, Visfeldt J. Cryptorchidism: aspects of fertility and neoplasms. A study including data of 1,335 consecutive boys who underwent testicular biopsy simultaneously with surgery for cryptorchidism. Horm Res. 2001;55(1):21-7. doi: 10.1159/000049959.
- Background: PubMed 17476009Pettersson A, Richiardi L, Nordenskjold A, Kaijser M, Akre O. Age at surgery for undescended testis and risk of testicular cancer. N Engl J Med. 2007 May 3;356(18):1835-41. doi: 10.1056/NEJMoa067588.
- Background: PubMed 29183799Xing JS, Bai ZM. Is testicular dysgenesis syndrome a genetic, endocrine, or environmental disease, or an unexplained reproductive disorder? Life Sci. 2018 Feb 1;194:120-129. doi: 10.1016/j.lfs.2017.11.039. Epub 2017 Nov 26.
- Background: PubMed 17875492Olesen IA, Sonne SB, Hoei-Hansen CE, Rajpert-De Meyts E, Skakkebaek NE. Environment, testicular dysgenesis and carcinoma in situ testis. Best Pract Res Clin Endocrinol Metab. 2007 Sep;21(3):462-78. doi: 10.1016/j.beem.2007.04.002.
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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.
Nicolas KALFA, Prof principal investigator
University Hospital, Montpellier
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 Hypospadias, run by University Hospital, Montpellier 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 0 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 26 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas KALFA, Prof (0467338784, n-kalfa@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of toxic exposure via hair sample analysis (time frame: Day 1 (Visit 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06628375, which also lists 25 linked publications.
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 26 Nov 2025.