Меню
Идёт набор NCT07560852

Impact of Endotest on Patients' Quality of Life: a Cohort Study

— Наблюдательное Patient With a Prescribed Endotest Endometriosis (Diagnosis)

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: Questionnaire.
Кому может быть актуально
Состояния в реестре: Patient With a Prescribed Endotest, Endometriosis (Diagnosis). Базовые параметры: 18 лет — 43 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

Ziwig Endotest® ('Endotest') is marketed in several countries, including Switzerland, which was the first country to make it available in 2022. Since February 2025, several French clinical investigation sites have been offering Endotest, developed by Ziwig, under the innovation funding. Initially, this innovation funding enabled 2,500 patients to be included in a clinical trial (ENDOBEST: ID-RCB 2024-A02092-45). Since the end of December 2025, it has been expanded and now covers a further 22,500 patients whose are not included in the trial. This medical device is based on Next-Generation Sequencing combined with analytical algorithms and enables the identification of endometriosis from a saliva sample. This non-invasive test aims to improve patient care by reducing diagnostic delays and guiding treatment strategies. Despite the available data on its diagnostic performance, the impact of Endotest on patients' quality of life, their emotional experience, their coping strategies, and their care pathways remains insufficiently documented. Indeed, the Endotest result (positive or negative) can significantly influence these various aspects. This cohort study aims to assess the impact of Endotest on patients' quality of life, primarily using validated self-report questionnaires and clinical data from medical records. By including a large sample of patients, this study aims to provide robust and generalisable data that will be useful for clinicians and patients themselves.

Вмешательства

  • Другое Questionnaire
    EHP 5+6, RAND-36 et 6 and 12 months follow-up visits

Первичные конечные точки

  • To assess the impact of Endotest on quality of life and identify the factors associated with quality of life. [Срок оценки: Day 1, 6 months and 12 months.]
  • To assess the impact of Endotest on quality of life and identify the factors associated with quality of life. [Срок оценки: Day 1, 6 months and 12 months]
  • To assess the impact of Endotest on quality of life and identify the factors associated with quality of life. [Срок оценки: 6 months]
  • To assess the impact of Endotest on quality of life and identify the factors associated with quality of life. [Срок оценки: 6 months]
Вторичные конечные точки (9)
  • Describe the impact of Endotest on adaptation strategies. [Срок оценки: 6 months]
  • Describe the impact of Endotest on the assisted reproductive technology (ART) journey (including infertility assessment and fertility preservation). [Срок оценки: Through study completion, an average of 1 year]
  • Describe the impact of Endotest on the assisted reproductive technology (ART) journey (including infertility assessment and fertility preservation). [Срок оценки: Through study completion, an average of 1 year]
  • Describe the impact of Endotest's results immediately following the announcement. [Срок оценки: 1 month]
  • Describe the impact of Endotest on patient care: tests, treatments, and additional procedures (e.g., laparoscopy). [Срок оценки: Through study completion, an average of 1 year]
  • Describe the impact of Endotest on patient care: tests, treatments, and additional procedures (e.g., laparoscopy). [Срок оценки: Through study completion, an average of 1 year]
  • To assess the impact of Endotest on anxiety levels. [Срок оценки: 1 month]
  • Compare the care provided to patients with a positive Endotest result across participating countries. [Срок оценки: Through study completion, an average of 1 year]
  • Compare pelvic sensitivity based on Endotest results [Срок оценки: Day 1 and 12 months]

Критерии участия

Критерии включения

  • Women with a prescription for Endotest
  • Women aged 18 to 43
  • Who have dated and signed the consent form
  • Affiliated with the French healthcare system or covered by health insurance abroad

Критерии исключения

  • Contraindications for the use of Endotest:
  • Current pregnancy;
  • Medical history of cancer or HIV infection;
  • Active infection at the time of saliva collection;
  • Significant difficulty reading and understanding the language of the country in which the participant is located.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 7 центров
  • Clinique Tivoli Ducos — Bordeaux
  • Hôpital privé Saint-Grégoire — Saint-Grégoire
  • Groupe Hospitalier Bretagne Sud - GHBS - Lorient — Lorient
  • Hôpital de Mercy - CHR Metz Thionville — Peltre
  • CHU de Saint Etienne — Saint-Priest-en-Jarez
  • Centre Hospitalier de Pau — Pau
  • Hôpital Jacques Monod - GH du Havre — Montivilliers

Идентификаторы

NCT: NCT07560852 · 2025ZW03 · 2026-A00166-45

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗