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Идёт набор NCT04723095

Establishing a Tumor Registry for Patients With Neuroendocrine Carcinoma of the Cervix

Наблюдательное Cervical Large Cell Neuroendocrine Carcinoma Cervical Neuroendocrine Carcinoma Cervical Small Cell Carcinoma Cervical Undifferentiated Carcinoma

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: Follow-Up, Medical Chart Review.
Кому может быть актуально
Состояния в реестре: Cervical Large Cell Neuroendocrine Carcinoma, Cervical Neuroendocrine Carcinoma, Cervical Small Cell Carcinoma, Cervical Undifferentiated Carcinoma. Базовые параметры: Без ограничений · 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This study collects information and data on patients with neuroendocrine cervical cancer. Information from this study may be used to better understand the correlation between clinical data, such as patient characteristics, treatment, and disease outcomes, and overall patient outcomes.

Подробное описание

PRIMARY OBJECTIVES:

I. To collect, both prospectively and retrospectively, data on disease characterization, treatment, and outcomes for patients with neuroendocrine carcinoma of the uterine cervix.

II. To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome.

III. To have a single data repository kept on a secure platform that will integrate clinical information and research findings and serve as an archive for future research.

OUTLINE:

Patients' medical records are reviewed retrospectively and prospectively. All prospective patients will be contacted via email, telephone, or U.S. Mail on case by case basis for up to 10 years to check status of disease and any further treatment received. Project staff can also access the patient's M. D. Anderson Epic medical record for updates. Request for additional clinic and treatment notes will be submitted to external medical institutions listed in the physician information form in order to access updated notes for non- M. D. Anderson patients

Вмешательства

  • Другое Follow-Up
    Receive follow up
  • Другое Medical Chart Review
    Review of medical records

Первичные конечные точки

  • Disease characterization data [Срок оценки: through study completion, an average of 1 year]
  • Patient treatment data [Срок оценки: through study completion, an average of 1 year]
  • Patient outcome data [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • Patients with a personal history of cervical cancer with any portion of neuroendocrine component (including mixed tumors) of the following histologic subtypes:
  • Small cell neuroendocrine carcinoma
  • Large cell neuroendocrine carcinoma
  • Undifferentiated high-grade neuroendocrine carcinoma
  • Patients may be in any stage of treatment, surveillance or recurrence at the time of initial participation in the study
  • Patients with all stages of disease are considered eligible
  • Patients who do not speak English can be eligible if accompanied by an institutional interpreter
  • Patients who are receiving or have received treatment at any facility, including but not limited to M. D. Anderson Cancer Center are eligible
  • Patient may be residents of any country and be of any ethnic background
  • Patients who request to participate in the study, regardless of the method by which they learned of it, are eligible to participate, including, but not limited to patients who seek participation via the website
  • Next of kin or legal authorized representatives of patients who are deceased but had a history of neuroendocrine carcinoma (NEC) of the cervix are eligible to participate
  • Next of kin or legal authorized representatives of patients must read and speak English

Критерии исключения

  • Patients with other histologic subtypes of NEC of the cervix including typical and atypical carcinoid tumors

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • M D Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT04723095 · PA12-1006 · NCI-2020-07408 · PA12-1006

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗