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Идёт набор NCT06007794

Correlation Between Ultrasound-assessed Quadriceps Muscle Mass and Baseline Whole-body Densitometry Muscle Index in the Post-cancer Population (JUMP Research II)

Без фазы С лечением Cancer Post-cancer Hematology

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: JUMP group.
Кому может быть актуально
Состояния в реестре: Cancer, Post-cancer, Hematology. Базовые параметры: 18 лет — 74 лет · 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Therapeutic advances in oncology have transformed the prognosis of cancer patients, placing a significant number of them either in a context of recovery or in prolonged remission close to a chronic disease. Thus, the reconquest of a life after cancer becomes possible but raises many challenges for the patient, his entourage, the medical profession and our society. One of the major challenges is the detection and management of treatment side effects for all patients. In addition to the standard organic assessment (glycaemia, creatinine, liver test, blood count), we are mainly interested in muscle deconditioning and cognitive impairment, which are particularly disturbed in these populations. After the evaluation day, patients are referred to the most appropriate structures (Adapted physical activity, sports for health, and rehabilitation at Henry Gabriel Hospital). JUMP research is part of axis 2 of the 2021-2030 cancer plan: "Limiting sequelae and improving quality of life", through sheets 1 (research) / 6 (access and quality) / 7 (prevention). This leads to the concrete implementation on the territory of adapted care channels in the city: medical structure, physiotherapy, Adapted Physical Activity (APA) structures, associative structures; which makes it possible to develop and strengthen the city-hospital link. Finally, it allows the patient to take ownership and get involved in the project, allowing in the future to make them truly active in they care and to advise and motivate their peers. This non-interventional research is classified as "research involving human subjects", class 3 . The objective of this research is to evaluate the impact of cancer on the musculoskeletal system and to test ultrasound as a clinical examination for the detection of sarcopenia in this population.

Вмешательства

  • Другое JUMP group
    patients will have a femoral ultrasound and blood tubes in addition to the blood sample taken as part of the treatment

Первичные конечные точки

  • Analyze the correlation between muscle mass (thickness) of the quadriceps (rectus femoris) assessed in axial sections by ultrasound and the reference muscle mass index (Appendicular Lean Mass (ALM)/height²) assessed by DEXA [Срок оценки: through study completion, an average of 9 years]
Вторичные конечные точки (6)
  • Correlation between the ultrasound muscle indexes and the scannographic index of the paravertebral muscles (SMI L3, T12 and T7, studied by IA) [Срок оценки: through study completion, an average of 9 years]
  • Correlation between ultrasound muscle indices and muscle functional tests [Срок оценки: through study completion, an average of 9 years]
  • Correlation between muscle biological markers (irisin, myostatin, FGF19, TGFb, decarboxylated osteocalcin, microRNA) and the diagnosis of sarcopenia (according to EWSGOP 2019 and BAUMGARTNER) [Срок оценки: through study completion, an average of 9 years]
  • Correlation between muscle biological markers (irisin, myostatin, FGF19, TGFb, decarboxylated osteocalcin, microRNA) and ultrasound, densitometric, scannographic and functional parameters [Срок оценки: through study completion, an average of 9 years]
  • Reproducibility of muscle ultrasound, in a subgroup of patients, inter-observer (n=10 patients) [Срок оценки: through study completion, an average of 9 years]
  • Reproducibility of muscle ultrasound, in a subgroup of patients, intra-observer (n=10 patients). [Срок оценки: through study completion, an average of 9 years]

Критерии участия

Критерии включения

  • Age : 18 to 74 years
  • localization of the primitive: breast, lung, melanoma, testicle, bladder, kidney, ovary, colon and pancreas, hemopathy
  • patient who benefited from the post-cancer assessment day

Критерии исключения

  • Active cancer (relapse or new cancer)
  • Pregnant or breastfeeding women
  • Major cognitive impairment making comprehension and exercise difficult
  • Amputation of both lower limbs (for ultrasound)
  • Difficulty understanding oral and written French
  • Adults under legal protection (guardianship, curatorship or safeguard of justice)

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
Профилактика

Центры проведения

Франция · 1 центр
  • Hôpital Lyon Sud, rhumatologie — Pierre-Bénite

Идентификаторы

NCT: NCT06007794 · 69HCL23_0368

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗