Меню
Идёт набор NCT05372484

Rice Technologies for Cervical Cancer Screening and Diagnosis

Без фазы С лечением Cervical Cancer

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: Multimodal optical imaging.
Кому может быть актуально
Состояния в реестре: Cervical Cancer. Базовые параметры: 25 лет — 49 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
США, Mozambique
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 →

Официальное название

Assessment of New Technologies for the Screening and Diagnosis of Cervical Cancer in Mozambique, A Study to be Conducted in Maputo Central Hospital, Mavalane and Jose Macamo General Hospitals and Mavalane Health Center

Обзор

The study aims to compare the accuracy of the lateral flow test to detect HPV at the POC with commercially available HPV test and to determine the diagnostic accuracy and reliability of a multimodal optical imaging system to detect cervical dysplasia, with the gold reference standard of histopathology.

Подробное описание

This is a prospective, single-arm community trial involving 678 women aged 25 to 49 years for evaluation of positive cervical cancer screening tests (abnormal cytology, VIA+ and/or HPV+ test). Eligible women will be offered enrollment at the time of their consultation for a follow-up of their abnormal cervical cancer screening test.

Participating centers include: 1) Mavalane Hospital and Health Center and 2) José Macamo General Hospital (José Macamo), 3) Maputo Central Hospital. After providing the informed consent, the participant will answer a short questionnaire that will include demographic information and medical background, including HIV status (HIV-negative, positive, or unknown, and, among women with HIV-positive tests, HIV viral load and CD4 cell count, if available), and cervical cancer screening test results.

The patient will undergo a rapid urine - POC pregnancy test (within 14 days from the date of enrollment). Each participant will then receive instructions and will provide two cervico-vaginal samples taken by the patient herself (self-collection).

The patient will then undergo a pelvic examination with two cervical samples taken by the healthcare provider. 7. A sample taken by the patient herself (self-collection) and a sample taken by the provider will be sent for an HPV test using GeneXpert. Similarly, samples taken by the patient herself (self-collection) and collected by the provider will be stored for the Rice POC rapid HPV test.

The patient will then undergo multimodal imaging. Images/videos of the cervix will be obtained using the mobile colposcope/smartphone and HRME images/videos will be also obtained.

Вмешательства

  • Устройство Multimodal optical imaging
    Women referred for colposcopy due to abnormal cervical screening will be recruited into the experimental group of the study. Imaging of study participants will take place during the colposcopy examination.

Первичные конечные точки

  • Development of multimodal optical imaging system [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • 25 - 49 year old women
  • Women with a positive cervical cancer screening test (abnormal cytology, positive VIA and/or positive HPV test)
  • Women with intact cervix
  • Women who are not pregnant and with a negative pregnancy test (within 14 days from the date of enrollment) ) and not currently breastfeeding
  • Willing and capable of providing informed consent

Критерии исключения

  • Women under 25 or over 49 years old
  • Women who have undergone a total hysterectomy (with removal of the cervix)
  • Women who are pregnant or breastfeeding

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
Скрининг

Центры проведения

Mozambique · 3 центра
  • José Macamo General Hospital and Health Center — Maputo
  • Maputo Central Hospital — Maputo
  • Mavalane Hospital and Health Center — Maputo
США · 1 центр
  • M D Anderson Cancer Center — Houston

Публикации

  • Novak EN, Hansen CJ, Wazir Z, Ma A, Carns J, Atif H, Montealegre JR, Scheurer ME, Lorenzoni C, Rosen DG, Salcedo MP, Schmeler KM, Richards-Kortum RR. Point-of-care hrHPV mRNA detection with reverse transcription recombinase polymerase amplification on a portable fluorimeter from provider-collected cervical samples in Maputo, Mozambique. Infect Agent Cancer. 2026 Jun 23;21(1):52. doi: 10.1186/s1302 PMID 42337609

Идентификаторы

NCT: NCT05372484 · 2020-0549 · NCI-2022-03776

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗