DiagnosticGynoBizhNCT06828536
Female Genital Schistosomiasis in Migrant Women: A Pilot Study
A study testing Gynecology consultation, Transvaginal ultrasound and PCR Schistosoma spp in people with Diagnostic and Schistosomiasis, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
This pilot study, "GynoBizh," investigates the frequency and clinical characteristics of female genital schistosomiasis (FGS) among migrant women from sub-Saharan Africa living in non-endemic countries. Schistosomiasis is a significant global parasitic disease, with a high seroprevalence in migrants. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Diagnostic, Schistosomiasis
- What is being tested?
- Gynecology consultation, Transvaginal ultrasound and PCR Schistosoma spp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2025to 10 Aug 2026
- Phase
- Interventional
- 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 25 to 65 years
- Born in a schistosomiasis-endemic area in sub-Saharan Africa
- With a positive serology by Schistosoma spp. Western Blot
Who cannot join
- Refusal to participate in the study
- Patient unable to provide consent
- Patient under guardianship or trusteeship
- Patient who is a virgin at the time of selection
- Patient who is pregnant at the time of selection
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This pilot study, "GynoBizh," investigates the frequency and clinical characteristics of female genital schistosomiasis (FGS) among migrant women from sub-Saharan Africa living in non-endemic countries. Schistosomiasis is a significant global parasitic disease, with a high seroprevalence in migrants. The study aims to assess the presence of genital lesions through gynecological examinations, colposcopy, and molecular tests, identifying diagnostic markers and associated health conditions. Fifty participants will be followed over a year to improve understanding and management of FGS in underserved populations.
Read the detailed description
Female genital schistosomiasis (FGS) is an underdiagnosed and under-researched condition, particularly in non-endemic regions, despite its significant prevalence among migrant women from sub-Saharan Africa. Schistosomiasis is the second most common parasitic disease globally, with a seroprevalence of up to 25% among migrants from endemic regions. FGS, characterized by genital lesions, often goes unrecognized due to a lack of awareness among healthcare providers in non-endemic countries and the absence of a gold-standard diagnostic method.
This pilot study, conducted at Bicêtre Hospital by Assistance Publique - Hôpitaux de Paris, seeks to evaluate the frequency of FGS-related genital lesions in a cohort of 50 women aged 25-65 years. Participants, all seropositive for schistosomiasis and originating from sub-Saharan Africa, will be recruited over six months and followed for one year. The study involves a comprehensive diagnostic approach, including gynecological examinations, colposcopy, endovaginal ultrasounds, and molecular tests (e.g., PCR on vaginal self-samples and cervical smears). Lesions identified during initial exams will be reassessed at follow-ups scheduled at 3, 6, and 12 months.
Secondary objectives include documenting participants' gynecological and obstetric histories, symptoms, and potential co-infections with HIV, HBV, and HCV. The study will also compare the effectiveness of different diagnostic tools for FGS and explore the presence of Schistosoma DNA in plasma and genital samples. Data will be collected through clinical assessments, questionnaires, and laboratory analyses, with results analyzed using robust statistical methods.
While the procedures are minimally invasive, risks are low and limited to mild discomfort from colposcopy and minor bleeding following biopsies. This study is expected to yield valuable insights into the prevalence and characteristics of FGS in non-endemic settings, addressing an overlooked health issue that disproportionately affects migrant women. By highlighting diagnostic challenges and identifying effective tools, this research aims to inform clinical guidelines, improve care, and advocate for targeted public health strategies for this vulnerable population.
- Conditions
- Diagnostic, Schistosomiasis
- Being tested
- Gynecology consultation, Transvaginal ultrasound, PCR Schistosoma spp
- Keywords
- femal genital schistosomiasis, migrant women, colposcopy, Diagnostic pilot study, Schistosoma spp. PCR
- Medical subject headings
- Disease, Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gynecology consultationOther
Gynecology consultation M0 - M3 - M6 - M12
Transvaginal ultrasoundOther
Transvaginal ultrasound
PCR Schistosoma sppOther
PCR Schistosoma spp Colposcopy Cervical biopsy Cervical smear
| Study group | Role | What they receive |
|---|---|---|
| group | Experimental | Not described Receives: Other: Gynecology consultation; Other: Transvaginal ultrasound; Other: PCR Schistosoma spp |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the frequency of lower genital involvement due to schistosomiasis (perineum, vulva, vagina, cervix) in women born in endemic areas in sub-Saharan Africa and living in non-endemic countries who have positive serology for schistosomiasis
The frequency of lower genital involvement in women who are seropositive for schistosomiasis, as seen on gynaecological examination of the vulva, vagina and cervix using the speculum and of the cervix using colposcopy, carried out during the dedicated gynaecology consultation prior to treatment
Measured: 12 months
Secondary outcomes (7)
Take a gynaecological history of schistosomiasis-positive women with or without proven FGS (gestational age, parity, miscarriages, ectopic pregnancies, infertility, HPV infection, upper genital infection)
Personal gynaecological history: number of pregnancies, number of children, miscarriages, ectopic pregnancies, percentage of infertility (defined as no pregnancy after 1 year of the trial), number of HPV infections (condyloma, cervical dysplasia), number of upper genital infections, etc.
Measured: inclusion
Describe the gynaecological and urological symptoms of patients infected with schistosomiasis
Percentage of women with urological symptoms: dysuria, burning, nocturia, pollakiuria, macroscopic haematuria, microscopic haematuria
Measured: inclusion
Describe the specific clinical lesions of FGS on colposcopy and vulvar and endovaginal examination
Percentage of women with gynaecological symptoms: vulvar pruritus, abnormal leucorrhoea, menometrorrhagia, dyspareunia, dysmenorrhoea, pelvic pain, etc.
Measured: inclusion
To describe the ultrasound lesions of the genital tract found in patients who are seropositive for schistosomiasis
Percentage of women with ultrasound genital tract lesions compatible with schistosomiasis
Measured: inclusion
Compare positivity rates of tests for FGS: (i) Schistosoma spp. PCR on vaginal self-sampling, (ii) lesions at colposcopy, (iii) Schistosoma spp. PCR on cervical/vaginal smears, (iv) cervical biopsy, (v) egg detection on cervical/vaginal smears
Percentage of women with a positive test among : (i) Schistosoma spp. PCR on vaginal self-sampling, (ii) specific lesions seen at colposcopy, (iii) Schistosoma spp. PCR on cervical and vaginal smears, (iv) cervical biopsy, (v) egg testing on cervical and vaginal smears
Measured: inclusion
Determining the presence of HIV, HBV and HCV co-infection
Percentage of co-infection by determination of HIV, HBV, HCV serology
Measured: inclusion
To determine the presence of Schistosoma spp. DNA in plasma in the event of positive serology in this context of chronic bilharzian infection
Percentage of positive Schistosoma spp PCRs on vaginal self-sampling and Number of patients with Schistosoma spp PCR in serum
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start10 Feb 2025 (estimated)
- Primary completion10 Aug 2026 (estimated)
- Study completion10 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiagnosticStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828536
- Sponsor's protocol ID
- APHP240729
- Acronym
- GynoBizh
- Status last verified
- Jan 2025
- First submitted
- 10 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Female Genital Schistosomiasis in Migrant Women: A Pilot Study
- ClinicalTrials.gov ID
- NCT06828536
- Acronym / sponsor ID
- GynoBizh / APHP240729
- Conditions
- Diagnostic, Schistosomiasis
- Keywords
- femal genital schistosomiasis, migrant women, colposcopy, Diagnostic pilot study, Schistosoma spp. PCR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Feb 2025 (estimated)
- Primary completion
- 10 Aug 2026 (estimated)
- Study completion
- 10 Aug 2026 (estimated)
- First posted
- 14 Feb 2025 (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 pilot study, "GynoBizh," investigates the frequency and clinical characteristics of female genital schistosomiasis (FGS) among migrant women from sub-Saharan Africa living in non-endemic countries. Schistosomiasis is a significant global parasitic disease, with a high seroprevalence in migrants. The study aims to assess the presence of genital lesions through gynecological examinations, colposcopy, and molecular tests, identifying diagnostic markers and associated health conditions. Fifty participants will be followed over a year to improve understanding and management of FGS in underserved populations.
Detailed description
Female genital schistosomiasis (FGS) is an underdiagnosed and under-researched condition, particularly in non-endemic regions, despite its significant prevalence among migrant women from sub-Saharan Africa. Schistosomiasis is the second most common parasitic disease globally, with a seroprevalence of up to 25% among migrants from endemic regions. FGS, characterized by genital lesions, often goes unrecognized due to a lack of awareness among healthcare providers in non-endemic countries and the absence of a gold-standard diagnostic method.
This pilot study, conducted at Bicêtre Hospital by Assistance Publique - Hôpitaux de Paris, seeks to evaluate the frequency of FGS-related genital lesions in a cohort of 50 women aged 25-65 years. Participants, all seropositive for schistosomiasis and originating from sub-Saharan Africa, will be recruited over six months and followed for one year. The study involves a comprehensive diagnostic approach, including gynecological examinations, colposcopy, endovaginal ultrasounds, and molecular tests (e.g., PCR on vaginal self-samples and cervical smears). Lesions identified during initial exams will be reassessed at follow-ups scheduled at 3, 6, and 12 months.
Secondary objectives include documenting participants' gynecological and obstetric histories, symptoms, and potential co-infections with HIV, HBV, and HCV. The study will also compare the effectiveness of different diagnostic tools for FGS and explore the presence of Schistosoma DNA in plasma and genital samples. Data will be collected through clinical assessments, questionnaires, and laboratory analyses, with results analyzed using robust statistical methods.
While the procedures are minimally invasive, risks are low and limited to mild discomfort from colposcopy and minor bleeding following biopsies. This study is expected to yield valuable insights into the prevalence and characteristics of FGS in non-endemic settings, addressing an overlooked health issue that disproportionately affects migrant women. By highlighting diagnostic challenges and identifying effective tools, this research aims to inform clinical guidelines, improve care, and advocate for targeted public health strategies for this vulnerable population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group | Experimental | Other: Gynecology consultation, Other: Transvaginal ultrasound, Other: PCR Schistosoma spp |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 25 to 65 years
- Born in a schistosomiasis-endemic area in sub-Saharan Africa
- With a positive serology by Schistosoma spp. Western Blot
Key exclusion criteria (5 listed)
- Refusal to participate in the study
- Patient unable to provide consent
- Patient under guardianship or trusteeship
- Patient who is a virgin at the time of selection
- Patient who is pregnant at the time of selection
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 |
|---|---|---|
| Gynecology consultationGynecology consultation M0 - M3 - M6 - M12 | Other | group |
| Transvaginal ultrasoundTransvaginal ultrasound | Other | group |
| PCR Schistosoma sppPCR Schistosoma spp Colposcopy Cervical biopsy Cervical smear | Other | group |
Primary outcome
To determine the frequency of lower genital involvement due to schistosomiasis (perineum, vulva, vagina, cervix) in women born in endemic areas in sub-Saharan Africa and living in non-endemic countries who have positive serology for schistosomiasis
Time frame: 12 months
The frequency of lower genital involvement in women who are seropositive for schistosomiasis, as seen on gynaecological examination of the vulva, vagina and cervix using the speculum and of the cervix using colposcopy, carried out during the dedicated gynaecology consultation prior to treatment
7 secondary outcomes
Take a gynaecological history of schistosomiasis-positive women with or without proven FGS (gestational age, parity, miscarriages, ectopic pregnancies, infertility, HPV infection, upper genital infection)
Time frame: inclusion
Describe the gynaecological and urological symptoms of patients infected with schistosomiasis
Time frame: inclusion
Describe the specific clinical lesions of FGS on colposcopy and vulvar and endovaginal examination
Time frame: inclusion
To describe the ultrasound lesions of the genital tract found in patients who are seropositive for schistosomiasis
Time frame: inclusion
Compare positivity rates of tests for FGS: (i) Schistosoma spp. PCR on vaginal self-sampling, (ii) lesions at colposcopy, (iii) Schistosoma spp. PCR on cervical/vaginal smears, (iv) cervical biopsy, (v) egg detection on cervical/vaginal smears
Time frame: inclusion
Determining the presence of HIV, HBV and HCV co-infection
Time frame: inclusion
To determine the presence of Schistosoma spp. DNA in plasma in the event of positive serology in this context of chronic bilharzian infection
Time frame: inclusion
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 14 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Gynecology consultation, Transvaginal ultrasound and PCR Schistosoma spp in people with Diagnostic and Schistosomiasis, run by Assistance Publique - Hôpitaux de Paris.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Emma OLIOSI, Dr (+33 1 45 21 21 21, emma.oliosi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the frequency of lower genital involvement due to schistosomiasis (perineum, vulva, vagina, cervix) in women born in endemic areas in sub-Saharan Africa and living in non-endemic countries who have positive serology for schistosomiasis (time frame: 12 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 14 Feb 2025.