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Идёт набор NCT06969833

Prospective Clinico-biological Database of Patients With Ovarian and/or Peritoneal and/or Fallopian Tube Carcinoma

Без фазы С лечением Cancer of the Ovary Cancer of the Fallopian Tube Peritoneal 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: Constitution of a biological collection, Assessment of Quality of Life and level of anxiety/depression.
Кому может быть актуально
Состояния в реестре: Cancer of the Ovary, Cancer of the Fallopian Tube, Peritoneal 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Study of Prognostic Factors Associated With Overall Survival in Patients Initially Treated for Advanced Ovarian and/or Peritoneum and/or Fallopian Tubes Carcinoma: Analysis Using a Prospective Clinico-Biological Database

Обзор

Cancer of the ovary and/or peritoneum and/or fallopian tube have a very poor prognosis, and require the implementation of collaborative research tools and new innovative therapies. The main objective of this study is to implement prognostic model of overall survival on patients included prospectively as part of the initial treatment of advanced ovarian and/or peritoneum, and/or fallopian tubes carcinoma (this cohort corresponds to the "Turquoise" care pathway of the Oscar Lambret Center) regardless of the treatment carried out,, integrating both patient's and tumor's characteristics. A clinical and biological database is implemented for this purpose. 371 patients will be recruited over a 5-year period at the Oscar Lambret Center. The active participation of each patient will be 2 years (from the date of pre-registration until the end of study participation, defined by the date of the last intervention specific to the research), then the data from standard care and survival data will be collected until the last follow-up of the last patient, 2 years after the last pre-registration.

Подробное описание

This study is part of the management of patients with advanced ovarian and/or peritoneal carcinoma, and/or fallopian tubes (initial treatment) at the Oscar Lambret Center.

Once consent is obtained, pre-registration of patient on the trial is possible during initial care, from diagnosis and before the confirmation of FIGO stage; a trial number is assigned to the patient.

If the diagnosis of advanced invasive ovarian and/or peritoneal and/or fallopian tube carcinoma is confirmed (FIGO stage IIB to IV), the patient is included. On the contrary (FIGO stage IA to IIA, or other disease), patient is not included on the trial and excluded from analysis.

Pre-registration and inclusion are possible the same day if the definitive FIGO stage is confirmed.

However, this project differs from standard care with:

* an additional blood sample, collected once inclusion is confirmed (28ml) * left-over routine samples collected from pre-registration until two years after pre-registration (tumor samples, ascites, zetc.) * questionnaires about quality of life (QLQ-C30, QLQ-OV28) and anxiety (HADS) are completed after pre-registration, then after 3 and 6 courses of systemic treatment (at the time of laparoscopy or surgery), then every 3 months, up to 2 years after pre-registration. Patients can choose printed and/or digital questionnaires. * clinical data are entered into a trial-specific database ; in addition to overall survival, numerous variables will be studied, notably the clinical and socio-economic characteristics of the patients, their planned and effective treatment, the morbidity of treatments, event-free survival, evolution of the quality of life, etc. * Translational research works will be implemented later on left-over routine samples.

Вмешательства

  • Другое Constitution of a biological collection
    * Left-over tissue samples (tumor tissue of different nature) frozen and secured in paraffin, and derived from standard care, are collected at study entrance until the end of oncologic treatment. * One blood sample of 28mL is collected once inclusion is confirmed
  • Другое Assessment of Quality of Life and level of anxiety/depression
    Questionnaires QLQ-C30, OV-28 and HADS are completed by the patients after pre-registration, then after 3 and 6 cycles of systemic treatment, and every 3 months up to 2 years after pre-registration

Первичные конечные точки

  • To identify prognostic factors associated with overall survival on patients included prospectively as part of the initial treatment integrating both patient's and tumor's characteristics, using a multivariate Cox model. [Срок оценки: Up to 7 years after the first pre-registration]
Вторичные конечные точки (12)
  • To develop a prospective clinico-biological database of patients with advanced ovarian and/or peritoneal and/or fallopian tube carcinoma included during first-line treatment [Срок оценки: Up to 7 years after the first pre-registration]
  • To develop and validate prognostic models of event-free survival (EFS) on patients included prospectively as part of the initial treatment, integrating both patient's and tumor's characteristics, using a multivariate Cox model [Срок оценки: Up to 7 years after the first pre-registration]
  • To describe both initial characteristics of the patients and their disease characteristics [Срок оценки: At baseline]
  • To describe the therapeutic management of these patients, as planned initially and finally carried out [Срок оценки: Up to 7 years after the first pre-registration]
  • To describe the morbidity events of first-line treatments [Срок оценки: Up to 7 years after the first pre-registration]
  • To describe the distribution of events (recurrence or progression) on patients who have received platinum treatment [Срок оценки: Up to 7 years after the first pre-registration]
  • To estimate overall survival (OS) and event-free survival (EFS) of patients [Срок оценки: Up to 7 years after the first pre-registration]
  • To estimate post-relapse overall survival (OS), and post-relapse event-free survival (EFS) of patients [Срок оценки: Up to 7 years after the first pre-registration]
  • To assess the quality of life of patients according to the score calculated with the health-related quality of life questionnaire (QLQ-C30) [Срок оценки: After pre-registration, then after 3 and 6 courses of systemic treatment (up to 3 and 6 months), at the time of surgery, then every 3 months up to 2 years after pre-registration]
  • To assess the quality of life of patients according to the score calculated with the ovarian cancer module of the health-related quality of life questionnaire (QLQ-OV28) [Срок оценки: After pre-registration, then after 3 and 6 courses of systemic treatment (up to 3 and 6 months), at the time of surgery, then every 3 months up to 2 years after pre-registration]
  • To assess the level of anxiety of patients according to the anxiety score calculated with Hospital Anxiety and Depression scale [Срок оценки: After pre-registration, then after 3 and 6 courses of systemic treatment (up to 3 and 6 months), at the time of surgery, then every 3 months up to 2 years after pre-registration]
  • To assess the level of depression of patients according to the depression score calculated with Hospital Anxiety and Depression scale [Срок оценки: After pre-registration, then after 3 and 6 courses of systemic treatment (up to 3 and 6 months), at the time of surgery, then every 3 months up to 2 years after pre-registration]

Критерии участия

Eligibility criteria for pre-registration:

  • Patient aged 18 or over
  • Informed consent warranted
  • Patient affiliated to a social security regimen
  • Suspected diagnosis of advanced and invasive ovarian cancer and/or primary peritoneal cancer and/or fallopian tube cancer (IIB to IV FIGO stages)
  • Pre-registration during standard care at the Oscar Lambret Centre, from diagnosis and before confirmation of definitive FIGO stage

Non eligibility criteria for pre-registration:

  • Patient deprived of liberty or under curatorship or guardianship
  • Refusal to participate

Критерии включения

  • Confirmed diagnosis of advanced and invasive ovarian cancer and/or primary peritoneal cancer and/or fallopian tube cancer (IIB to IV FIGO stages)

Критерии исключения

  • Dismissed diagnosis of advanced and invasive ovarian cancer and/or primary peritoneal cancer and/or fallopian tube cancer , or other type of cancer

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
Другое

Центры проведения

Франция · 1 центр
  • Centre Oscar Lambret — Lille

Идентификаторы

NCT: NCT06969833 · BCB-OVAIRE-2205 · 2023-A02449-36

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗