Assessment of Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy

Weprom150 enrolled

Overview

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on the CT and PRONOPALL score data with a prevalence of sarcopenia of 60% and median overall survival of 14 months (unpublished data), clinical performance and muscle strength tests were not carried out (as in the publications cited above).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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Metastatic Cancer Cancer, Breast Cancer Colon

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient aged 18 years or older 2. 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) 3. Patient naive of cancer treatment 4. Pathology including performing a CT scan with cuts of the lumbar spine in standard care 5. Patient enrolled in social security 6. Patient has given his written consent ahead of any specific protocol procedure. Exclusion Criteria: 1. Minor patient 2. Metastatic neurological impairment 3. Patient deprived of their liberty, under guardianship or trusteeship 4. Patient with dementia, mental disorders or psychological pathology which could compromise patient informed consent and/or the observance of the study protocol 5. Patient cannot submit to the protocol for psychological, social, familial or geographical reasons 6. Patient is pregnant 7. History of cancer treated (excluding surgery alone for tumors in situ) within 5 years of inclusion

Outcomes

Primary Outcomes

Rate of patients with sarcopenia diagnosed with metastatic cancer.

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..

Time frame: At inclusion

Secondary Outcomes

Overall Survival

Calculated from the date of inclusion to the date of death due to any cause or the date last known to be alive if patient is censored.

Time frame: 18 months

Event Free survival

Calculated from the date of start of treatment to the date of first event (progression, death, infectious complications, thrombosis, side effects of treatments of grade 2 or higher)

Time frame: 18 months

Progression Free survival

Calculated from the date of start of treatment to the date of first progression of disease based on Investigator assessment or the date of death or censored at the date of the last valid tumor assessment before start of a new therapy for patients who are still alive and without progression

Time frame: 18 months

Unanticipated hospitalization rate

Calculated from the date of start of treatment for all unplanned hospitalizations for side effects of treatments of grade 2 or higher, infectious complications, thrombosis, relapse or progression

Time frame: 18 months

Statistical relationship between sarcopenia and the PRONOPALL score

For the cancer subtypes concerned (breast, colon, rectum, lungs, ovaries, prostate, kidney, pancreas)

Time frame: 18 months

Rate of undernourished patients

Calculated according to WHO classification

Time frame: 18 months

Rate of patients with sarcopenia at diagnosis across the inclusive population

Calculated from the number of patients who were screened for sarcopenia at diagnosis in the active file of patients meeting the inclusion criteria in all participating centers

Time frame: 18 months

Assessment of Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts