Assessment of the Proportion of Patients With Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Rate of patients with sarcopenia diagnosed with metastatic cancer.
研究概览
简要总结
Sarcopenia is defined as reduction in muscle mass and function according to the criteria of the European Working Group on Sarcopenia in older people. Initially described for elderly patients, it is also presented as a negative prognostic factor in overall survival in oncology in certain locations (lung, ENT pathways, colon, pancreas) and more controversially for hemopathies. Its screening by measurement of skeletal muscle mass by CT scan and / or PET scan against L3 and by physical functional tests is not routinely integrated despite international recommendations. Sarcopenia is one of the characteristics of patient fragility that can induce more complications, lengthen the average length of hospital stay and reduce overall survival. The PRONOPALL score, a predictor score for survival validated by a previous study, will be correlated with the presence (or absence) of sarcopenia at inclusion for patients with a solid tumor (breast, ovary, prostate cancer , kidney, lungs, pancreas, colorectal). A prospective study on 38 patients with metastatic cancer was carried out at the Victor Hugo clinic in Le Mans between 01/JUN/21 and 31/AUG/21 (SPACE, ClinicalTrials.gov number, NCT04714203): 25 patients were analyzable on the CT and PRONOPALL score data with a prevalence of sarcopenia of 60% and median overall survival of 14 months (unpublished data), clinical performance and muscle strength tests were not carried out (as in the publications cited above).
A prospective study for the detection of sarcopenia is indicated by extending to blood diseases with the integration of clinical tests included in the initial APA (Adapted physical activity) assessment recommended for diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 years or older
- •Patient with solid cancer diagnosed with metastatic disease,or hematological disease requiring treatment (myeloma, lymphoma, high-risk myelodysplasia, acute or chronic myeloid leukemia, acute and chronic lymphoid leukemia)
- •Patient naive of cancer treatment
- •Pathology including performing a CT scan with cuts of the lumbar spine in standard care
- •Patient enrolled in social security
- •Patient has given his written consent ahead of any specific protocol procedure.
排除标准
- •Minor patient
- •Metastatic neurological impairment
- •Patient deprived of their liberty, under guardianship or trusteeship
- •Patient with dementia, mental disorders or psychological pathology which could compromise patient informed consent and/or the observance of the study protocol
- •Patient cannot submit to the protocol for psychological, social, familial or geographical reasons
- •Patient is pregnant
- •History of cancer treated (excluding surgery alone for tumors in situ) within 5 years of inclusion
结局指标
主要结局
Rate of patients with sarcopenia diagnosed with metastatic cancer.
时间窗: At inclusion
Sarcopenia is defined for those under 60 years of age by LMSI\<43.1 cm²/m² for men and \<32.7 cm²/m² for women, and for patients over 60 years of age by \<38.6 cm²/m² for men and \<30.7 cm²/m² for women..
次要结局
- Overall Survival(18 months)
- Unanticipated hospitalization rate(18 months)
- Event Free survival(18 months)
- Progression Free survival(18 months)
- Statistical relationship between sarcopenia and the PRONOPALL score(18 months)
- Rate of undernourished patients(18 months)
- Rate of patients with sarcopenia at diagnosis across the inclusive population(18 months)