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Набор скоро начнётся NCT06828536

Female Genital Schistosomiasis in Migrant Women: A Pilot Study

Без фазы С лечением Diagnostic Schistosomiasis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Gynecology consultation, Transvaginal ultrasound, PCR Schistosoma spp.
Кому может быть актуально
Состояния в реестре: Diagnostic, Schistosomiasis. Базовые параметры: 25 лет — 65 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Gynecology consultation
    Gynecology consultation M0 - M3 - M6 - M12
  • Другое Transvaginal ultrasound
    Transvaginal ultrasound
  • Другое PCR Schistosoma spp
    PCR Schistosoma spp Colposcopy Cervical biopsy Cervical smear

Первичные конечные точки

  • 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 [Срок оценки: 12 months]
Вторичные конечные точки (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) [Срок оценки: inclusion]
  • Describe the gynaecological and urological symptoms of patients infected with schistosomiasis [Срок оценки: inclusion]
  • Describe the specific clinical lesions of FGS on colposcopy and vulvar and endovaginal examination [Срок оценки: inclusion]
  • To describe the ultrasound lesions of the genital tract found in patients who are seropositive for schistosomiasis [Срок оценки: 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 [Срок оценки: inclusion]
  • Determining the presence of HIV, HBV and HCV co-infection [Срок оценки: inclusion]
  • To determine the presence of Schistosoma spp. DNA in plasma in the event of positive serology in this context of chronic bilharzian infection [Срок оценки: inclusion]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06828536 · APHP240729

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗