NCT06828536

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Feb 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Feb 2025Aug 2026

First Submitted

Initial submission to the registry

February 10, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2026

Last Updated

February 14, 2025

Status Verified

January 1, 2025

Enrollment Period

1.5 years

First QC Date

February 10, 2025

Last Update Submit

February 10, 2025

Conditions

DiagnosticSchistosomiasis

Keywords

femal genital schistosomiasismigrant womencolposcopyDiagnostic pilot studySchistosoma spp. PCR

Outcome Measures

Primary Outcomes (1)

  • 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

    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)

    inclusion

  • Describe the gynaecological and urological symptoms of patients infected with schistosomiasis

    inclusion

  • Describe the specific clinical lesions of FGS on colposcopy and vulvar and endovaginal examination

    inclusion

  • To describe the ultrasound lesions of the genital tract found in patients who are seropositive for schistosomiasis

    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

    inclusion

  • +2 more secondary outcomes

Study Arms (1)

group

EXPERIMENTAL
Other: Gynecology consultationOther: Transvaginal ultrasoundOther: PCR Schistosoma spp

Interventions

Gynecology consultationOTHER

Gynecology consultation M0 - M3 - M6 - M12

group
Transvaginal ultrasoundOTHER

Transvaginal ultrasound

group
PCR Schistosoma sppOTHER

PCR Schistosoma spp Colposcopy Cervical biopsy Cervical smear

group

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DiseaseSchistosomiasis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsTrematode InfectionsHelminthiasisParasitic DiseasesInfectionsVector Borne Diseases

Central Study Contacts

Emma OLIOSI, Dr

CONTACT

+33 1 45 21 21 21emma.oliosi@aphp.fr

Stéphane JAUREGUIBERRY, Pr

CONTACT

+33 1 45 21 74 22stephane.jaureguiberry@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 14, 2025

Study Start

February 10, 2025

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

August 10, 2026

Last Updated

February 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share