Идёт набор NCT05833321

Prospective Study of Detection of Sarcopenia in Clinical Practice for Patient With Ovarian or Endometrial Cancer

Без фазы С лечением Ovarian Neoplasms Sarcopenia

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: Sarcopenia diagnostic test.
Кому может быть актуально: Состояния в реестре: Ovarian Neoplasms, Sarcopenia. 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 →

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Официальное название

Prospective Monocentric Study of the Detection of Sarcopenia in Clinical Practice in Patients With Ovarian or Endometrial Cancer Requiring Systemic Oncological Treatment

Обзор

Prospective monocentric study, non-randomized of the detection of sarcopenia in clinical practice in patients with ovarian or endometrial cancer requiring systemic oncological treatment. main question : Identify the criteria correlated with the presence of sarcopenia (defined by the measurement of the IMS by the CT-X method in L3) among the impedancemetry and the HAS malnutrition criteria. Data collection will be done at 6 months, 12 months after the date of inclusion.

Подробное описание

Primary objective:Identify the criteria correlated to the presence of sarcopenia (defined by the measurement of the IMS by the CT-X method in L3) among the impedancemetry and the HAS malnutrition criteria

Main judgment criteria : Comparison between the groups of patients with sarcopenia (Morphometric measurement of the musculoskeletal surface index \<39cm²/m² in L3 cross section) and without sarcopenia of the different evaluation criteria:

* Impedancemetry values:: muscle mass index in kg/m2 (IMS), fat-free mass in kg/m2 and metabolic activity index (phase angle) * Percentage of weight loss * BMI \< 18.5 kg/m2 * Quantified reduction in muscle mass and/or function for patients \< 70 years old * Quantified reduction in muscle mass and function for patients \> 70 years old * Physical tests: walking speed and "hand grip" dynamometer secondary objectives:- Proposal of a composite score for the detection of sarcopenia usable in clinical routine * Evaluation of nutritional intake * Evaluation of the severity of undernutrition * Verification of a correlation between the sarcopenia indices of ovarian and endometrial cancer * Evaluate tolerance profiles to systemic treatments with regard to sarcopenia figures * Assess the relationship between PFS, OS and sarcopenia index in cancer diagnosis secondary judgment criteria : * Statistical analysis of sarcopenia and undernutrition data * Quantification of ingestates (SEFI scale) +/- intake of oral nutritional supplement * Serological tests: NFS, CRP and Albuminemia * Comparison of sarcopenia index figures between ovarian and endometrial cancer * Collection of the grades of toxicities and adverse events to systemic treatments in parallel with the measurement of sarcopenia. * Correlation between progression-free survival, death and sarcopenia index at cancer diagnosis

Вмешательства

Диагностический тест Sarcopenia diagnostic test
measurement of impedance and physical tests ("hand grip" dynamometer, walking test), SEFI nutritional intake questionnaire

Первичные конечные точки

clinical screening for sarcopenia [Срок оценки: 36 month]
Proposal of a composite score for the detection of sarcopenia usable in clinical routine [Срок оценки: 36 month]

Критерии участия

Критерии включения

Patients at least 18 years old
Patient presenting with a diagnosis of cancer of ovarian origin with an indication for chemotherapy
Patient with a diagnosis of endometrial cancer with an indication for chemotherapy
Patient with no diagnosis of other types of cancer in the previous five years
Collection of consent
Patient affiliated to a Social Security scheme