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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01670-41 | Other Identifier | French Health Products Safety Agency |
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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on the CT and PRONOPALL score data with a prevalence of sarcopenia of 60% and median overall survival of 14 months (unpublished data), clinical performance and muscle strength tests were not carried out (as in the publications cited above).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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | Standard follow-up MNA, IPAQ, SARC-F and SarQOL questionnaire |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard | Other | Standard follow-up with clinical exams, functionnal test at baseline, Ct scan MNA, IPAQ, SARC-F and SarQOL questionnaires |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.. | At inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited during medical consultations or hospitalization in an onco-hematology service
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magali BALAVOINE | Contact | +33(0)241682940 | m.balavoine@ilcgroupe.fr | |
| Katell LE DU, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Katell LE DU, MD | Private Hospital of Confuent, Nantes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Victor Hugo/Centre Jean Bernard | Le Mans | 72000 | France |
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| 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 | 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 | 18 months |
| Statistical relationship between sarcopenia and the PRONOPALL score | For the cancer subtypes concerned (breast, colon, rectum, lungs, ovaries, prostate, kidney, pancreas) | 18 months |
| Rate of undernourished patients | Calculated according to WHO classification | 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 | 18 months |
| Clinique privé du Confluent | Nantes | 44000 | France |
|
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D001943 | Breast Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D008175 | Lung Neoplasms |
| D010051 | Ovarian Neoplasms |
| D011471 | Prostatic Neoplasms |
| D007680 | Kidney Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D054219 | Neoplasms, Plasma Cell |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D015470 | Leukemia, Myeloid, Acute |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D010182 | Pancreatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
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