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Идёт набор NCT06771193

Study on Disease Characteristics and Treatment in Locally Advanced or Recurrent / Metastatic Cervical Cancer in Italy

— Наблюдательное Cervical Cancer Locally Advanced Cervical Cancer Recurrent Cervical Cancer Metastatic 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Cervical Cancer, Locally Advanced Cervical Cancer, Recurrent Cervical Cancer, Metastatic Cervical Cancer. 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
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

RETRACE Study - Retrospective Observational Study Evaluating Disease Characteristics and Treatment Landscape of High-risk Locally Advanced (LA) or Recurrent / Metastatic (R/M) Cervical Cancer in Italy

Обзор

Multicenter, Observational, Retrospective charts review. Observational study with descriptive purpose only. Retrospective data capture in consecutive patients diagnosed with CC who attended the Oncologic Clinics from Jan 2018 to Dec 2021 (using medical records, either electronic or not), inserted in eCRF and analyzed.

Подробное описание

This is a multicenter, observational, retrospective study. The primary aim of this trial is to describe patients and disease characteristics, as well as treatment pattern of locally advanced and recurrent/metastatic cervical cancer (R/M and LACC) in Italy, through a retrospective data capture, from January 2018 to December 2021.

Eligible cervical cancer patients will be identified by reviewing medical records and physician notes (paper or electronic).

Disease will be defined as follow:

* Locally advanced cervical cancer: a large tumour within the cervix (more than 4cm) or it has grown into the tissues around the cervix, but the cancer has not spread to other organs; usually includes stage 2B, 3 and 4A (FIGO staging) * Recurrent cervical cancer: local tumour regrowth or development of distant metastasis discovered 6 months or more after complete regression of the treatment (26) * Metastatic cervical cancer: cancer spreads beyond the pelvis to other parts of the body; usually defined as stage 4B (FIGO staging) Moreover, the patients' characteristics will be stratified as low risk and high risk for locally advanced cervical cancer and differences between their treatment partners will be reported.

Первичные конечные точки

  • The proportion of patients receiving each different treatment pattern of LA, recurrent, and metastatic CC (%) [Срок оценки: Retrospective data capture from Jan 2018 to Dec 2021]
  • The proportion of patient with recurrence or dead after treatment and remission (%) [Срок оценки: Retrospective data capture from Jan 2018 to Dec 2021]
  • Median time from remission to recurrence [Срок оценки: Retrospective data capture from Jan 2018 to Dec 2021]
  • Number of lines of treatment [Срок оценки: Retrospective data capture from Jan 2018 to Dec 2021]
  • The costs in terms of resources utilization associated to the different treatment patterns of LA, recurrent and metastatic CC [Срок оценки: Retrospective data capture from Jan 2018 to Dec 2021]
Вторичные конечные точки (4)
  • The proportion of patients who undergone screening program (%) [Срок оценки: Retrospective data capture from Jan 2018 to Dec 2021]
  • HPV subtype typization, if available [Срок оценки: Retrospective data capture from Jan 2018 to Dec 2021]
  • History of HPV related lesions (CIN 2+ lesion) [Срок оценки: Retrospective data capture from Jan 2018 to Dec 2021]
  • The proportion of patients with PD-L1 >1% and >50% (%) [Срок оценки: Retrospective data capture from Jan 2018 to Dec 2021]

Критерии участия

Критерии включения

  • Patient (or their legally acceptable representatives) must have signed and dated the Informed Consent \& Privacy Form (ICF)
  • Age ≥18 years
  • Diagnosis of a cervical cancer
  • Locally advanced stage (not suitable for curative surgery) or recurrent or metastatic disease
  • Any treatment received between January 2018 and December 2021 for advanced disease

Критерии исключения

  • Patients participating in a pharmacological clinical trial for the treatment of advanced disease
  • Patients who participated in a clinical trial
  • Patients who were administered with Pembrolizumab, Olaparib or Levantinib or medications from these class of drugs

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 11 центров
  • Oncologia Medica Policlinico Sant'Orsola Malpighi — Bologna
  • Ginecologia ed Ostetricia A.O. Cannizzaro — Catania
  • Oncologia Medica 1 IRCCS Ospedale Policlinico San Martino — Genova
  • Unità di Ginecologia Oncologica Medica IRCCS Ospedale San Raffaele — Milan
  • Unità Ostetricia, Ginecologia e Ginecologia Oncologica medica Humanitas San Pio X — Milan
  • Oncologia A.O.U. di Modena - Policlinico — Modena
  • U.O.S. Trattamenti Innovativi dell'utero Istituto Nazionale Tumori IRCCS "Fondazione G. Pa — Naples
  • UOC Oncologia Medica ed Ematologia Azienda Ospedaliera Universitaria Luigi Vanvitelli — Naples
  • … и ещё 3 центра

Идентификаторы

NCT: NCT06771193 · NIS102062

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗