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Идёт набор NCT03622983

Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization

Наблюдательное Pelvic Neoplasms Endometriosis

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: collection of sample and data.
Кому может быть актуально
Состояния в реестре: Pelvic Neoplasms, Endometriosis. Базовые параметры: от 18 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 →

Обзор

The management of pelvic gynecological cancers (PGC) is based on the determination of extension to guide treatments. The biology of the CGP is constantly evolving and personalized medicine adapted to this biology is currently in full development. For example, sequencing ovarian tumors can select patients who can benefit from anti-PARP therapy. There is therefore a need for patients to have biological samples of their tumor. Various studies on ovarian, endometrial and cervical cancer have sought to identify the factors predictive of recurrence of these cancers. The results obtained are very promising. This study will permit to collect biological samples and detailed clinical data that would allow to test hypotheses and develop a personalized medicine based on clinical and biological characteristics of patients.

Подробное описание

The management of pelvic gynecological cancers (PGC) is based on the determination of the extension in order to guide the treatments. The biology of PGC is constantly evolving and personalized medicine adapted to this biology is currently in full development. For example, sequencing of ovarian tumors allows selection of patients who may benefit from anti-PARP therapy. There is therefore a need for patients to have biological samples of their tumor. Various studies on ovarian, endometrial and cervical cancer have sought to identify factors that predict recurrence of these cancers. The results have obtained are very promising, but if coordinator team have at our disposal fundamental and translational data related to the prognosis of PGCs, the coordinator team lack access to a biological collection of these cancers that would allow us to test our hypotheses and to develop personalized medicine related to the clinico-biological characteristics of the patients.

Endometriosis is the 1st cause of chronic pelvic pain (25-40% of women suffering during sexual intercourse) and represents the 1st cause of school and work absenteeism. Unfortunately, it is under-diagnosed and too often inappropriately managed. It is considered that 10 to 15% of the female population of reproductive age has endometriosis. This incidence reaches 50% in women with infertility. There are many similarities between deep endometriosis and pelvic cancers, whether on a physiopathological, epidemiological or clinical level. There are therefore many similarities in the surgical management as well as in the research strategies.

Вмешательства

  • Другое collection of sample and data
    Recovery of surgical waste during surgery planned in the current care and clinical data collection

Первичные конечные точки

  • circulating tumor and DNA [Срок оценки: 2 years]
  • Endometriosis tumor and DNA [Срок оценки: 2 years]
Вторичные конечные точки (9)
  • circulating tumor DNA [Срок оценки: 5 years]
  • circulating tumor DNA [Срок оценки: 10 years]
  • circulating Micro RNA [Срок оценки: 2 years]
  • circulating Micro RNA [Срок оценки: 5 years]
  • circulating Micro RNA [Срок оценки: 10 years]
  • circulating cytokines [Срок оценки: 2 years]
  • circulating cytokines [Срок оценки: 5 years]
  • circulating cytokines [Срок оценки: 10 years]
  • Tumoral DNA [Срок оценки: day of surgery]

Критерии участия

Критерии включения

  • Diagnosis of pelvic gynecological cancer posed on initial histological analysis or during recurrence;
  • Or diagnosis of endometriosis on histology or imaging
  • Age ≥ 18 years;
  • Affiliation to the general social security scheme;
  • Consent signed.

Критерии исключения

  • Refusal of the patient;
  • Non-affiliation to the general social security scheme.

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 · 2 центра
  • CHI Creteil — Créteil
  • CHU Tenon — Paris

Идентификаторы

NCT: NCT03622983 · PELVIMASS2 · 2016-A00613-48

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗