Identification of Molecular Signatures of High-risk Oncogenic HPV and Study of Their Associations With the Presence of High-grade Lesions and/or Anal Cancer 10 Years After Inclusion in the ANRS IPERGAY Trial
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: High-resolution anoscopy.
- Кому может быть актуально
- Состояния в реестре: HPV Infection, Anal Cancer. Базовые параметры: от 18 лет · Все.
- 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 →
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Обзор
HPVsign is a cross-sectional, non-comparative, multicenter study involving all participants included in the HPV substudy of the ANRS IPERGAY trial. The study proposes to evaluate the cumulative incidence of high-grade lesions and/or anal cancers using high-resolution anoscopy (HRA) during the HPVsign study and/or diagnosed since the end of participation in the ANRS IPERGAY trial.
Подробное описание
The study aims to enrol 80 to 100 participants in French clinical centres. All the participants have participated to the IPERGAY HPV substudy.
The study proposes to evaluate the cumulative incidence of high-grade lesions and/or anal cancers using high-resolution anoscopy (HRA) during the HPVsign study and/or diagnosed since the end of participation in the ANRS IPERGAY trial.
Also, the study proposes to:
* study the association between the presence of HSIL and/or anal cancer and HPV molecular signatures during participation in the ANRS IPERGAY trial and 10 years after. * study the evolution of HPV molecular signatures from participation in the ANRS IPERGAY to current study * compare HRA results with anal cytology results * compare the results of anal cytology concomitant with HRA with those obtained during participation in the ANRS IPERGAY trial. * study factors associated with the presence of HSIL and/or anal cancer. * compare the presence of different HPV virus types in the oropharynx concomitant with HRA and during participation in the ANRS IPERGAY trial.
Вмешательства
- Процедура High-resolution anoscopy
The study includes 2 visits: * a medical consultation for inclusion * a proctology consultation including the performance of an AHR associated or not with biopsy sampling
Первичные конечные точки
- High-Grade Squamous Intraepithelial Lesion (HSIL) and/or anal cancers diagnosed by an high-resolution anoscopy (HRA) [Срок оценки: Within the 10 years prior to HPV sign study participation, or at the study proctological examination in the study.]
Вторичные конечные точки (5)
- HPV molecular signatures obtained using the Capture-HPV technique: HPV mutations, integration into the human genome [Срок оценки: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.]
- Nature of abnormalities on High resolution anoscopy (HRA): condylomas, lesions. [Срок оценки: 10 years after participation in the ANRS IPERGAY trial]
- Nature of abnormalities on anal cytology: lesions location, lesions type, lesions grade. [Срок оценки: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.]
- Nature of abnormalities on anal histology of lesions: location, type, grade [Срок оценки: 10 years after participation in the ANRS IPERGAY trial]
- Presence of different HPV virus types in the oropharynx [Срок оценки: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.]
Критерии участия
Критерии включения
- Participant in the ANRS IPERGAY clinical trial who was included in the initial HPV sub-study;
- Informed and written signed consent
- Participant with regular health insurance
Критерии исключения
- Participant under guardianship or curatorship
- Participant with free State medical assistance
- Participant who disagrees with the use of data collected as part of their participation in the ANRS IPERGAY trial.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Франция · 3 центра
- Hôpital de la Croix Rousse - SMIT — Lyon
- Hôpital Saint-Louis - SMIT — Paris
- Hôpital Tenon - SMIT — Paris
Идентификаторы
NCT: NCT06522256 · ANRS0251s-HPVSign